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Cardiopulmonary bypass (CPB) for cardiac operations may be accompanied by different patterns of visceral underperfusion. This could result in clinical patterns of lactic acidosis but in the most severe cases there is the risk for mesenteric infarction (0.2% of the cases). Renal function as well may be impaired due to a low oxygen delivery, and acute renal failure occurs in 1-2% of cases.
Fenoldopam mesilate is a selective splanchnic vasodilator when used at a dose < 0.1 mcg/kg/min.
The experimental hypothesis of this randomized, controlled trial (RCT) is that the use of fenoldopam may determine a better visceral perfusion during CPB.
Randomized placebo-controlled double blinded study. Patients undergoing complex cardiac operations will be randomly allocated to the study or the control group.
All the patients will receive the standard of care of our Institution. Adequacy of CPB perfusion will be assessed using oxygen delivery calculation, lactate production, SvO2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenoldopam mesilate | Drug | Continuous intravenous infusion at 0.1 mcg/kg/min starting immediately before CPB and ending after 12 hours from the end of the operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak blood lactate levels during CPB | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Urine output during CPB | 3 hours | |
| Peak blood lactate levels during the postoperative period | 48 hours after the end of the operation | |
| Peak serum creatinine level during the postoperative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Ranucci, M.D. | IRCCS Policlinico S. Donato | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico S.Donato | San Donato Milanese | Milan | 20097 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15464494 | Background | Ranucci M, Soro G, Barzaghi N, Locatelli A, Giordano G, Vavassori A, Manzato A, Melchiorri C, Bove T, Juliano G, Uslenghi MF. Fenoldopam prophylaxis of postoperative acute renal failure in high-risk cardiac surgery patients. Ann Thorac Surg. 2004 Oct;78(4):1332-7; discussion 1337-8. doi: 10.1016/j.athoracsur.2004.02.065. | |
| 39607014 |
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| ID | Term |
|---|---|
| D000140 | Acidosis, Lactic |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018818 | Fenoldopam |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo | Drug | Intravenous infusion (saline) Infused at the same rate (ml/h) as the experimental drug |
|
|
| 48 hours after the end of the operation |
| Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2. |
| 20332738 | Derived | Ranucci M, De Benedetti D, Bianchini C, Castelvecchio S, Ballotta A, Frigiola A, Menicanti L. Effects of fenoldopam infusion in complex cardiac surgical operations: a prospective, randomized, double-blind, placebo-controlled study. Minerva Anestesiol. 2010 Apr;76(4):249-59. |
| D051437 |
| Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |