Prospective randomized double-blind study to evaluate the superiority of Vasopressin versus Norepinephrine in the management of the patient at renal risk undergoing cardiac surgery with cardiopulmonary bypass (NOVACC trial)

Am Heart J. 2024 Jun:272:86-95. doi: 10.1016/j.ahj.2024.03.008. Epub 2024 Mar 16.

Abstract

Background: Cardiac surgery-associated acute kidney injury (CS-AKI) affects up to 30% of patients, increasing morbidity and healthcare costs. This condition results from complex factors like ischemia-reperfusion injury and renal hemodynamic changes, often exacerbated by surgical procedures. Norepinephrine, commonly used in cardiac surgeries, may heighten the risk of CS-AKI. In contrast, vasopressin, a noncatecholaminergic agent, shows potential in preserving renal function by favorably affecting renal hemodynamic. Preliminary findings, suggest vasopressin could reduce the incidence of CS-AKI compared to norepinephrine. Additionally, vasopressin is linked to a lower incidence of postoperative atrial fibrillation, another factor contributing to longer hospital stays and higher costs. This study hypothesizes that vasopressin could effectively reduce CS-AKI occurrence and severity by optimizing renal perfusion during cardiac surgeries.

Study design: The NOVACC trial (NCT05568160) is a multicenter, randomized, double blinded superiority-controlled trial testing the superiority of vasopressin over norepinephrine in patients scheduled for cardiac surgery with cardiopulmonary bypass (CPB). The primary composite end point is the occurrence of acute kidney injury and death. The secondary end points are neurological, cardiologic, digestive, and vasopressor related complications at day 7, day 30, day 90, hospital and intensive care unit lengths of stay, medico-economic costs at day 90.

Conclusion: The NOVACC trial will assess the effectiveness of vasopressin in cardiac surgery with CPB in reducing acute kidney injury, mortality, and medical costs.

Clinical trial registration: NCT05568160.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Kidney Injury* / epidemiology
  • Acute Kidney Injury* / etiology
  • Acute Kidney Injury* / prevention & control
  • Cardiac Surgical Procedures* / methods
  • Cardiopulmonary Bypass* / adverse effects
  • Cardiopulmonary Bypass* / methods
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Norepinephrine* / therapeutic use
  • Postoperative Complications / epidemiology
  • Postoperative Complications / prevention & control
  • Prospective Studies
  • Vasoconstrictor Agents* / therapeutic use
  • Vasopressins* / therapeutic use

Substances

  • Norepinephrine
  • Vasopressins
  • Vasoconstrictor Agents

Associated data

  • ClinicalTrials.gov/NCT05568160