NCT05647200: PRIME part II

Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass, Part II

Status unknown NA Last updated 26 April 2023

What this trial tests

NA trial testing Treatment: additional albumin during cardiopulmonary bypass in Endothelial Dysfunction in 64 participants. Status unknown.

Timeline

15 October 2023

Primary endpoint
15 July 2024

15 January 2025

Quick facts

Lead sponsor	Amsterdam UMC, location VUmc
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	15 October 2023
Primary completion	15 July 2024
Estimated completion	15 January 2025
Sites	1 location across Netherlands

Drugs / interventions tested

• Treatment: additional albumin during cardiopulmonary bypass — full drug profile →
• control: additional ringers during cardiopulmonary bypass — full drug profile →

Conditions studied

• Endothelial Dysfunction — all drugs for Endothelial Dysfunction →
• Hemolysis — all drugs for Hemolysis →
• Fluid Overload — all drugs for Fluid Overload →

Sponsor

Amsterdam UMC, location VUmc — full company profile →

Who can join

18 and older, any sex, with Endothelial Dysfunction or Hemolysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute microcirculatory perfusion disturbances is common in critical illness and associated with increased morbidity and mortality. Recent findings by our group showed that microcirculatory perfusion is disturbed during cardiac surgery with cardiopulmonary bypass (CPB) and remain disturbed up to 72 (seventy two) hours after surgery. A cardiopulmonary bypass is a machine which takes over heart and lung function, during the procedure. The disturbed microcirculation is associated with organ dysfunction induced by cardiac surgery using CPB, which is frequently seen (up to forty two percent, 42%) and results in a six-fold increase in mortality rate. The underlying cause of disturbed microcirculation is a higher endothelial permeability and vascular leakage and are a consequence of systemic inflammation, hemodilution (dilution of blood), hypothermia and hemolysis (breakdown of red blood cells). To gain the knowledge regarding disturbed microcirculation the investigators previously showed that hemodilution attributes to this disturbed perfusion. Hemodilution lowers colloid oncotic pressure (COP). Also, COP is affected by free hemoglobin, which increases with hemolysis and attributes to a disturbed microcirculation following CPB. This is interesting, as to the best of our knowledge, the effect of minimizing hemodilution and hemolysis during cardiac surgery on the microcirculatory perfusion has never been investigated, but could be the key factor in reducing organ dysfunction.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.