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The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac surgery patients. Systemic inflammatory response initiated by CPB through releasing of several mediators lead to altered endothelial integrity and in consequence the leakage of proteins and fluids from the intravascular to the interstitial compartment is occurred. Increased capillary permeability and decreased colloid osmotic pressure were shown to play a key role for fluid shift and increasing of extravascular water. Further tissue edema can result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to adverse outcomes.
Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid shift from the intracellular and the interstitial spaces of tissue into the intravascular compartment.
The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7.2% NaCl /hydroxyethyl starch 200/0.5 | Active Comparator | On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) |
|
| 0.9% NaCl | Placebo Comparator | On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Extravascular Lung Water Index | Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to "Predicted Body Weight". | baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Oxygenation | Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure. | 24 hours |
| Oxygen Delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir V Lomivorotov, MD, PhD | Novosibirsk Research Institute of Pathology of Circulation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk Research Institute of Pathology of Circulation | Novosibirsk | Novosibirsk Territory | 630055 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24549094 | Derived | Lomivorotov VV, Fominskiy EV, Efremov SM, Nepomniashchikh VA, Lomivorotov VN, Chernyavskiy AM, Shilova AN, Karaskov AM. Infusion of 7.2% NaCl/6% hydroxyethyl starch 200/0.5 in on-pump coronary artery bypass surgery patients: a randomized, single-blind pilot study. Shock. 2014 Mar;41(3):193-9. doi: 10.1097/SHK.0000000000000087. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 |
| FG001 | 0.9% NaCl (Control Group) | On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 0.9% NaCl |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Extravascular Lung Water Index | Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to "Predicted Body Weight". | Posted | Median | Inter-Quartile Range | mL/kg | baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group) | On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Evgeny Fominskiy | Academician EN Meshalkin State Budget Research Institute of Circulation Pathology | +79139538754 | evfominskiy@gmail.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D004487 | Edema |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 0.9% NaCl |
| Drug |
|
|
Oxygen delivery index (DO2I) will be used to assess this outcome measure.
| 24 hours |
| Cardiac Index | 24 hours |
| Fluid Balance | Net fluid balance at the end of surgery equals the sum of all infusions minus the urine output. Net fluid balance at postoperative day 1 equals the sum of all infusions minus the urine output and blood loss. | 24 hours |
| Inflammation Response | Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure. | 24 hours |
| Endothelial Integrity | Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure. | 24 hours |
| Plasma Na | 24 hours |
| Plasma Osmolarity | 24 hours |
| Rate of Acute Kidney Injury | serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure. | 48 hours |
| Rate of Hyperchloremic Metabolic Acidosis | blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure. | 24 hours |
| Stroke Volume Index | 24 hours |
| Rate of Neurological Complications | Delirium, clinically diagnosed stroke, and encephalopathy. | 24 hours |
| Blood Loss | Bleeding from chest tubes | 24 hours |
| Duration of Mechanical Ventilation | 24 hours |
| Chloride Loading | The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay | 24 h |
| 0.9% NaCl (Control Group) |
On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 0.9% NaCl |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 0.9% NaCl (Control Group) | On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 0.9% NaCl |
|
|
| Secondary | Pulmonary Oxygenation | Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure. | Not Posted | 24 hours |
| Secondary | Oxygen Delivery | Oxygen delivery index (DO2I) will be used to assess this outcome measure. | Not Posted | 24 hours |
| Secondary | Cardiac Index | Not Posted | 24 hours |
| Secondary | Fluid Balance | Net fluid balance at the end of surgery equals the sum of all infusions minus the urine output. Net fluid balance at postoperative day 1 equals the sum of all infusions minus the urine output and blood loss. | Not Posted | 24 hours |
| Secondary | Inflammation Response | Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure. | Not Posted | 24 hours |
| Secondary | Endothelial Integrity | Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure. | Not Posted | 24 hours |
| Secondary | Plasma Na | Not Posted | 24 hours |
| Secondary | Plasma Osmolarity | Not Posted | 24 hours |
| Secondary | Rate of Acute Kidney Injury | serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure. | Not Posted | 48 hours |
| Secondary | Rate of Hyperchloremic Metabolic Acidosis | blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure. | Not Posted | 24 hours |
| Secondary | Stroke Volume Index | Not Posted | 24 hours |
| Secondary | Rate of Neurological Complications | Delirium, clinically diagnosed stroke, and encephalopathy. | Not Posted | 24 hours |
| Secondary | Blood Loss | Bleeding from chest tubes | Not Posted | 24 hours |
| Secondary | Duration of Mechanical Ventilation | Not Posted | 24 hours |
| Secondary | Chloride Loading | The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay | Not Posted | 24 h |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 0.9% NaCl (Control Group) | On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) 0.9% NaCl | 0 | 20 | 0 | 20 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |