Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 20030595 | Registry Identifier | 151/2003/70403 Swedish Medical Product Agency) | |
| M76-05 | Other Identifier | Regional Ethical Review Board in Linkoping |
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| Name | Class |
|---|---|
| Region Örebro County | OTHER |
| Blekingesjukhuset, Karlskrona | UNKNOWN |
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The main purpose of this study is to determine whether intravenous glutamate infusion given in association with surgery for unstable coronary artery disease can protect the heart from myocardial injury, postoperative heart failure and death.
Myocardial preservation in cardiac surgery has mainly focused on the period when the heart is arrested (cross-clamp time). Today the heart can be arrested for up to 2-3 hours without major consequences. However, in spite of comparatively short cross-clamp times approximately 10% of the patients undergoing coronary surgery sustain significant myocardial injury whereas perioperative myocardial infarction is rare in aortic valve surgery despite longer cross-clamp times. The reason for this is that preoperative ischemia, and to some extent postoperative ischemia, remain major risk factors for development of myocardial infarction in patients with ischemic heart disease. In light of this, we suggest that efforts to improve outcome and reduce permanent myocardial damage should focus on the preoperative and the postoperative phase of coronary surgery. Furthermore, efforts should be instituted to reduce reperfusion injury and minimize permanent myocardial damage in long-standing or severe myocardial ischemia.
Metabolic intervention with intravenous glutamate infusion, offers the prospect of addressing the issues above and extending myocardial protection into the pre- and postoperative phase. Glutamate is an important substrate for the intermediary metabolism of the heart, particularly in association with ischemia. The effects of glutamate are partly related to its role in the malate-aspartate shuttle, transporting reducing equivalents across the mitochondrial membrane, regulating the NAD/NADH balance in the cytosol of the cells, and thereby enhancing anaerobic glycolysis during ischemia. Furthermore, glutamate contributes to an alternative anaerobic pathway for regeneration of high-energy phosphates, by substrate level phosphorylation in the Krebs cycle. Glutamate also improves clearance of metabolic waste produced during ischemia such as lactate and NH3, by taking part in the reactions involving transamination of pyruvate to alanine and of glutamate to glutamine. During reperfusion glutamate contributes to the replenishment of Krebs cycle intermediates lost during ischemia, which is essential for recovery of oxidative metabolism.
Administration of glutamate to patients with stable angina pectoris has been found to increase tolerance to stress-induced ischemia. Ischemia before onset of cardiopulmonary bypass has been established as a major risk factor for postoperative myocardial infarction. Patients with unstable coronary artery disease may have critical ischemia at rest and are particularly vulnerable to the increased oxygen demands during the early stages of coronary surgery. In a pilot study on patients operated urgently for unstable angina we found metabolic signs compatible with improved tolerance to ischemia before surgery and improved recovery of oxidative metabolism during early reperfusion. These results warrant further studies to evaluate the potential clinical benefit of preoperative glutamate infusion extended into the early postoperative period.
Comparisons: Intravenous infusion of 0.125 M glutamic acid solution v saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Preliminary power analysis (80% power; p<0.05) suggests that 2214 patients will be required with regard to primary end-point assuming 30% reduction of events occurring in 12% of untreated patients.
Stage I of the study comprises 800 patients* and will lead to an interim analysis with report of secondary end-points** and recalculation of sample-size with regard to primary end-point. An adaptive design with regard to primary end-point and analysis performed by external statistician blinded to the investigators will be used to avoid increasing the risk for type I error.
*Patient number 800 is anticipated to be enrolled during the summer of 2009 and for practical reasons all patients enrolled until the end of August 2009 will comprise the interim analysis.
**Secondary end-points include analysis of markers for myocardial injury (CK-MB, troponin-T), markers for hemodynamic adequacy (mixed venous oxygen saturation), renal function (p-creatinine, p-Cystatin C), brain injury (S100B, clinical signs). As a substudy a blinded analysis of the value of NT-pro BNP (obtained immediately before surgery, 24 hours postoperatively and on the 3rd postoperative day) as marker of postoperative heart failure and outcome will be conducted. NT-pro BNP will also be related to treatment with glutamate or placebo. Similar evaluation will involve markers troponin-T, p-Cystatin C and mixed venous oxygen saturation. For further details see outcome measures.
Substudies will involve subgroup analyses of patients with regard to combined CABG + valve procedures, severely unstable patients requiring emergency surgery / intravenous nitrates, preoperative LV-dysfunction and patients with diabetes. For further details see outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous glutamate | Active Comparator | Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. |
|
| Saline infusion | Placebo Comparator | Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous infusion of saline | Drug | Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Perioperative Myocardial Infarction, Postoperative Heart Failure or Postoperative Mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Perioperative Myocardial Injury | p-CK-MB postoperative day 1, p-troponin-T postoperative day 3 | perioperative |
| Postoperative Hemodynamic State | Mixed venous oxygen saturation (SvO2) measured at weaning from cardiopulmonary bypass and on arrival to ICU |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Svedjeholm, MD PhD | University Hospital, Linkoeping | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blekingesjukhuset, Karlskrona | Karlskrona | SE-371 85 | Sweden | |||
| University Hospital, Linköping |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3970360 | Background | Slogoff S, Keats AS. Does perioperative myocardial ischemia lead to postoperative myocardial infarction? Anesthesiology. 1985 Feb;62(2):107-14. doi: 10.1097/00000542-198502000-00002. | |
| 11191945 | Background | Dahlin LG, Olin C, Svedjeholm R. Perioperative myocardial infarction in cardiac surgery--risk factors and consequences. A case control study. Scand Cardiovasc J. 2000 Oct;34(5):522-7. doi: 10.1080/140174300750064710. |
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4 patients, 2 in each group were excluded because of intraoperative exclusion criteria
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Glutamate | Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. |
| FG001 | Saline Infusion | Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Glutamate | Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Perioperative Myocardial Infarction, Postoperative Heart Failure or Postoperative Mortality | Posted | Count of Participants | Participants | 30 days |
|
All-cause mortality over a 10-year period. Serious and Other adverse events assessed over 30 days or in hospital
All-cause mortality was monitored over a 10-year period. Serious and Other adverse events were monitored/assessed over 30 days or in hospital
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Glutamate | Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous glutamate infusion: Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke < 24 hours | Nervous system disorders | Systematic Assessment | Stroke within 24 hours of surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative nausea | Gastrointestinal disorders | Non-systematic Assessment | Postoperative nausea as reported by attending nurse |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rolf Svedjeholm | Dept Cardiothoracic Surgery, Linköping University Hospital, SE58185 Linköping, Sweden | +46101034825 | rolf.svedjeholm@regionostergotland.se |
Not provided
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
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| Intravenous glutamate infusion | Other | Intravenous infusion of 0.125 M glutamic acid solution at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. |
|
| Until arrival to ICU |
| Postoperative Hemodynamic State in Patients With Severely Reduced Left Ventricular Ejection Fraction (LVEF<0.40) | Hemodynamic instability despite inotropes or need for IABP at the end of surgery in patients with severely reduced left ventricular ejection fraction (LVEF<0.40) | End of surgery |
| Postoperative Renal Function | maximum p-creatinine value recorded postoperatively < 30 days | 30 days |
| Number of Participants With Postoperative Stroke < 24 Hours | Incidence of Postoperative stroke < 24 hours of surgery verifed by CT-scan | 24 hours |
| ICU Stay | ICU duration of stay (hours) | ICU stay |
| Atrial Fibrillation | Number of patients with atrial fibrillation recorded postoperatively | Hospital stay |
| Severe Circulatory Failure in CCS Class IV Patients | Severe circulatory failure according to prespecified criteria as judged by a blinded endpoints committee in CCS class IV patients | 30 days |
| 10-year Survival | 10-year survival - related to intervention. Last follow-up August 3, 2022. Follow-up time ranged from 12.7-16.8 years. | 10 year - survival (crude) |
| Postoperative Mortality | Postoperative mortality within 30 days of surgery | 30 days |
| Linköping |
| SE-581 85 |
| Sweden |
| University Hospital, Örebro | Örebro | SE 701 85 | Sweden |
| 993339 | Background | Mudge GH Jr, Mills RM Jr, Taegtmeyer H, Gorlin R, Lesch M. Alterations of myocardial amino acid metabolism in chronic ischemic heart disease. J Clin Invest. 1976 Nov;58(5):1185-92. doi: 10.1172/JCI108571. |
| 6129934 | Background | Thomassen AR, Nielsen TT, Bagger JP, Henningsen P. Myocardial exchanges of glutamate, alanine and citrate in controls and patients with coronary artery disease. Clin Sci (Lond). 1983 Jan;64(1):33-40. doi: 10.1042/cs0640033. |
| 2707269 | Background | Pisarenko OI, Baranov AV, Aleshin OI, Studneva IM, Pomerantsev EA, Nikolaeva LF, Savchenko AP, Pavlov NA. Features of myocardial metabolism of some amino acids and ammonia in patients with coronary artery disease. Eur Heart J. 1989 Mar;10(3):209-17. doi: 10.1093/oxfordjournals.eurheartj.a059468. |
| 1967510 | Background | Thomassen A, Botker HE, Nielsen TT, Thygesen K, Henningsen P. Effects of glutamate on exercise tolerance and circulating substrate levels in stable angina pectoris. Am J Cardiol. 1990 Jan 15;65(3):173-8. doi: 10.1016/0002-9149(90)90080-k. |
| 1858669 | Background | Thomassen A, Nielsen TT, Bagger JP, Pedersen AK, Henningsen P. Antiischemic and metabolic effects of glutamate during pacing in patients with stable angina pectoris secondary to either coronary artery disease or syndrome X. Am J Cardiol. 1991 Aug 1;68(4):291-5. doi: 10.1016/0002-9149(91)90821-2. |
| 1361429 | Background | Thomassen AR. Myocardial uptake and effects of glutamate during non-ischaemic and ischaemic conditions. A clinical study with special reference to possible interrelationships between glutamate and myocardial utilization of carbohydrate substrates. Dan Med Bull. 1992 Dec;39(6):471-88. No abstract available. |
| 1405674 | Background | Beyersdorf F, Kirsh M, Buckberg GD, Allen BS. Warm glutamate/aspartate-enriched blood cardioplegic solution for perioperative sudden death. J Thorac Cardiovasc Surg. 1992 Oct;104(4):1141-7. |
| 2890348 | Background | Pisarenko OI, Portnoy VF, Studneva IM, Arapov AD, Korostylev AN. Glutamate-blood cardioplegia improves ATP preservation in human myocardium. Biomed Biochim Acta. 1987;46(6):499-504. |
| 8461223 | Background | Suleiman MS, Fernando HC, Dihmis WC, Hutter JA, Chapman RA. A loss of taurine and other amino acids from ventricles of patients undergoing bypass surgery. Br Heart J. 1993 Mar;69(3):241-5. doi: 10.1136/hrt.69.3.241. |
| 8103947 | Background | Kimose HH, Ravkilde J, Helligso P, Knudsen MA, Thomassen AR, Nielsen TT, Djurhuus JC. Myocardial loss of glutamate after cold chemical cardioplegia and storage in isolated blood-perfused pig hearts. Thorac Cardiovasc Surg. 1993 Apr;41(2):93-100. doi: 10.1055/s-2007-1013829. |
| 2001026 | Background | Smith RC, Leung JM, Mangano DT. Postoperative myocardial ischemia in patients undergoing coronary artery bypass graft surgery. S.P.I. Research Group. Anesthesiology. 1991 Mar;74(3):464-73. doi: 10.1097/00000542-199103000-00013. |
| 2867848 | Background | Pisarenko OI, Lepilin MG, Ivanov VE. Cardiac metabolism and performance during L-glutamic acid infusion in postoperative cardiac failure. Clin Sci (Lond). 1986 Jan;70(1):7-12. doi: 10.1042/cs0700007. |
| 2008107 | Background | Svedjeholm R, Ekroth R, Joachimsson PO, Ronquist G, Svensson S, Tyden H. Myocardial uptake of amino acids and other substrates in relation to myocardial oxygen consumption four hours after cardiac operations. J Thorac Cardiovasc Surg. 1991 Apr;101(4):688-94. |
| 8975838 | Background | Svedjeholm R, Vanhanen I, Hakanson E, Joachimsson PO, Jorfeldt L, Nilsson L. Metabolic and hemodynamic effects of intravenous glutamate infusion early after coronary operations. J Thorac Cardiovasc Surg. 1996 Dec;112(6):1468-77. doi: 10.1016/S0022-5223(96)70005-3. |
| 9594855 | Background | Vanhanen I, Hakanson E, Jorfeldt L, Svedjeholm R. Intravenous aspartate infusion after a coronary operation: effects on myocardial metabolism and hemodynamic state. Ann Thorac Surg. 1998 May;65(5):1296-302. doi: 10.1016/s0003-4975(98)00155-6. |
| 9764429 | Background | Vanhanen I, Svedjeholm R, Hakanson E, Joachimsson PO, Jorfeldt L, Nilsson L, Vanky F. Assessment of myocardial glutamate requirements early after coronary artery bypass surgery. Scand Cardiovasc J. 1998;32(3):145-52. doi: 10.1080/14017439850140102. |
| 12775312 | Background | Vanhanen I, Hakanson E, Jorfeldt L, Svedjeholm R. Myocardial uptake and release of substrates in patients operated for unstable angina: impact of glutamate infusion. Scand Cardiovasc J. 2003 May;37(2):113-20. doi: 10.1080/14017430310001230. |
| 11343941 | Background | Svedjeholm R, Hakanson E, Szabo Z, Vanky F. Neurological injury after surgery for ischemic heart disease: risk factors, outcome and role of metabolic interventions. Eur J Cardiothorac Surg. 2001 May;19(5):611-8. doi: 10.1016/s1010-7940(01)00664-9. |
| 7840694 | Background | Svedjeholm R, Hakanson E, Vanhanen I. Rationale for metabolic support with amino acids and glucose-insulin-potassium (GIK) in cardiac surgery. Ann Thorac Surg. 1995 Feb;59(2 Suppl):S15-22. doi: 10.1016/0003-4975(94)00917-v. |
| 443452 | Background | Rau EE, Shine KI, Gervais A, Douglas AM, Amos EC 3rd. Enhanced mechanical recovery of anoxic and ischemic myocardium by amino acid perfusion. Am J Physiol. 1979 Jun;236(6):H873-9. doi: 10.1152/ajpheart.1979.236.6.H873. No abstract available. |
| 1673733 | Background | Engelman RM, Rousou JA, Flack JE 3rd, Iyengar J, Kimura Y, Das DK. Reduction of infarct size by systemic amino acid supplementation during reperfusion. J Thorac Cardiovasc Surg. 1991 May;101(5):855-9. |
| 7434210 | Background | Lazar HL, Buckberg GD, Manganaro AJ, Becker H, Maloney JV Jr. Reversal of ischemic damage with amino acid substrate enhancement during reperfusion. Surgery. 1980 Nov;88(5):702-9. |
| 6137148 | Background | Bittl JA, Shine KI. Protection of ischemic rabbit myocardium by glutamic acid. Am J Physiol. 1983 Sep;245(3):H406-12. doi: 10.1152/ajpheart.1983.245.3.H406. |
| 6430593 | Background | Haas GS, DeBoer LW, O'Keefe DD, Bodenhamer RM, Geffin GA, Drop LJ, Teplick RS, Daggett WM. Reduction of postischemic myocardial dysfunction by substrate repletion during reperfusion. Circulation. 1984 Sep;70(3 Pt 2):I65-74. |
| 6140002 | Background | Pisarenko OI, Solomatina ES, Studneva IM, Ivanov VE, Kapelko VI, Smirnov VN. Protective effect of glutamic acid on cardiac function and metabolism during cardioplegia and reperfusion. Basic Res Cardiol. 1983 Sep-Oct;78(5):534-43. doi: 10.1007/BF01906464. |
| 38252440 | Derived | Holm J, Vanky F, Svedjeholm R. Association of Glutamate Infusion With Risk of Acute Kidney Injury After Coronary Artery Bypass Surgery: A Pooled Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2024 Jan 2;7(1):e2351743. doi: 10.1001/jamanetworkopen.2023.51743. |
| 34253255 | Derived | Jiang H, Holm J, Friberg O, Vanky F, Vidlund M, Tajik B, Yang Y, Svedjeholm R. Utility of NT-proBNP as an objective marker of postoperative heart failure after coronary artery bypass surgery: a prospective observational study. Perioper Med (Lond). 2021 Jul 13;10(1):21. doi: 10.1186/s13741-021-00194-4. |
| 32393387 | Derived | Jiang H, Holm J, Vidlund M, Vanky F, Friberg O, Yang Y, Svedjeholm R. The impact of glutamate infusion on postoperative NT-proBNP in patients undergoing coronary artery bypass surgery: a randomized study. J Transl Med. 2020 May 11;18(1):193. doi: 10.1186/s12967-020-02351-7. |
| 27484576 | Derived | Vidlund M, Tajik B, Hakanson E, Friberg O, Holm J, Vanky F, Svedjeholm R. Post hoc analysis of the glutamics-trial: intravenous glutamate infusion and use of inotropic drugs after cabg. BMC Anesthesiol. 2016 Aug 2;16(1):54. doi: 10.1186/s12871-016-0216-z. |
| 24727704 | Derived | Holm J, Vidlund M, Vanky F, Friberg O, Hakanson E, Walther S, Svedjeholm R. EuroSCORE II and N-terminal pro-B-type natriuretic peptide for risk evaluation: an observational longitudinal study in patients undergoing coronary artery bypass graft surgery. Br J Anaesth. 2014 Jul;113(1):75-82. doi: 10.1093/bja/aeu088. Epub 2014 Apr 11. |
| 22989031 | Derived | Holm J, Vidlund M, Vanky F, Friberg O, Hakanson E, Svedjeholm R. Preoperative NT-proBNP independently predicts outcome in patients with acute coronary syndrome undergoing CABG. Scand Cardiovasc J Suppl. 2013 Feb;47(1):28-35. doi: 10.3109/14017431.2012.731518. Epub 2012 Oct 10. |
| 19853332 | Derived | Vidlund M, Holm J, Hakanson E, Friberg O, Sunnermalm L, Vanky F, Svedjeholm R. The S-100B substudy of the GLUTAMICS trial: glutamate infusion not associated with sustained elevation of plasma S-100B after coronary surgery. Clin Nutr. 2010 Jun;29(3):358-64. doi: 10.1016/j.clnu.2009.09.007. Epub 2009 Oct 22. |
| BG001 | Saline Infusion | Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease.
|
|
| Secondary | Degree of Perioperative Myocardial Injury | p-CK-MB postoperative day 1, p-troponin-T postoperative day 3 | Posted | Median | Inter-Quartile Range | µg/L | perioperative |
|
|
|
| Secondary | Postoperative Hemodynamic State | Mixed venous oxygen saturation (SvO2) measured at weaning from cardiopulmonary bypass and on arrival to ICU | Posted | Mean | Standard Deviation | percentage of saturated hemoglobin | Until arrival to ICU |
|
|
|
| Secondary | Postoperative Hemodynamic State in Patients With Severely Reduced Left Ventricular Ejection Fraction (LVEF<0.40) | Hemodynamic instability despite inotropes or need for IABP at the end of surgery in patients with severely reduced left ventricular ejection fraction (LVEF<0.40) | Moderately or severely reduced LVEF (<0.40) | Posted | Count of Participants | Participants | End of surgery |
|
|
|
| Secondary | Postoperative Renal Function | maximum p-creatinine value recorded postoperatively < 30 days | Posted | Mean | Standard Deviation | µmol/L | 30 days |
|
|
|
| Secondary | Number of Participants With Postoperative Stroke < 24 Hours | Incidence of Postoperative stroke < 24 hours of surgery verifed by CT-scan | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | ICU Stay | ICU duration of stay (hours) | Posted | Median | Inter-Quartile Range | hours | ICU stay |
|
|
|
| Secondary | Atrial Fibrillation | Number of patients with atrial fibrillation recorded postoperatively | Posted | Count of Participants | Participants | Hospital stay |
|
|
|
| Secondary | Severe Circulatory Failure in CCS Class IV Patients | Severe circulatory failure according to prespecified criteria as judged by a blinded endpoints committee in CCS class IV patients | CCS class IV patients | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | 10-year Survival | 10-year survival - related to intervention. Last follow-up August 3, 2022. Follow-up time ranged from 12.7-16.8 years. | Two patients were lost to follow-up, one in each group. One patient had moved abroad, the other one for unknown reason. | Posted | Count of Participants | Participants | 10 year - survival (crude) |
|
|
|
| Secondary | Postoperative Mortality | Postoperative mortality within 30 days of surgery | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 126 |
| 427 |
| 54 |
| 428 |
| 164 |
| 428 |
| EG001 | Saline Infusion | Intravenous infusion of saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. Intravenous infusion of saline: Intravenous infusion of isotonic saline at a rate of 1.65 ml/hour and kg body weight beginning with institution of anesthesia and stopping 2 hours after unclamping of aorta in patients operated for unstable coronary artery disease. | 131 | 432 | 59 | 433 | 165 | 433 |
|
| Severe circulatory failure | Cardiac disorders | Systematic Assessment | Postoperative heart failure according to prespecified criteria |
|
| Perioperative myocardial infarction | Cardiac disorders | Systematic Assessment | Troponin-T > 2.0 μg/L on the third or fourth postoperative day |
|
| Cardiac mortality | Cardiac disorders | Systematic Assessment | Death within 30 days or in hospital due to cardiac cause as determined by a blinded end-point committee |
|
| Postoperative dialysis | Renal and urinary disorders | Systematic Assessment | New onset dialysis postoperatively |
|
| Reoperation for bleeding | Blood and lymphatic system disorders | Systematic Assessment | Reoperation for bleeding during the postoperative course |
|
| Infection | Infections and infestations | Systematic Assessment | Infection requiring surgery (mainly deep sternal wound infections) |
|
| Postoperative mortality | Surgical and medical procedures | Systematic Assessment | All-cause mortality within 30 days of surgery |
|
|
| Postoperative atrial fibrillation | Cardiac disorders | Non-systematic Assessment | Postoperative atrial fibrillation recorded in the institutional database |
|
| Infection | Infections and infestations | Non-systematic Assessment | Postoperative infection not requiring surgery or extending hospital stay |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Respiratory problems (atelectasis, pleural effusion, respiratory discomfort, need for oxygen etc) reported but not extending hospital stay |
|
| Skin reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash, itching or other skin reaction reported by attending nurse |
|
Not provided
Not provided
| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |