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OpenTrials
Completed

NCT Number: NCT00747331

Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

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.

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Key information

Conditions

Cardiac Complications Acid-Base Imbalance Acidosis Acidosis, Lactic Acute Kidney Injury Cardiopulmonary Bypass Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS Policlinico S.Donato

San Donato Milanese, Milan, 20097, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Complex, combined cardiac operation
  • Predicted CPB duration > 90 minutes

Exclusion criteria

  • Age < 18 years
  • No written informed consent

Treatment and study plan

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

Other names: Corlopam

Placebo

Drug

Intravenous infusion (saline)

Infused at the same rate (ml/h) as the experimental drug

Other names: Saline

Primary outcomes

  1. Peak blood lactate levels during CPB

    Time frame: 3 hours

Secondary outcomes

  1. Urine output during CPB

    Time frame: 3 hours

  2. Peak blood lactate levels during the postoperative period

    Time frame: 48 hours after the end of the operation

  3. Peak serum creatinine level during the postoperative period

    Time frame: 48 hours after the end of the operation

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Registry information

Official study title

Fenoldopam Prophylaxis of Splanchnic Organs Underperfusion During Cardiopulmonary Bypass: a Randomized, Controlled Trial.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 5, 2008
Registry last updated
Apr 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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