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

NCT05647200 | Unknown

• 1 other identifier: NL82500.029.22, part II
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endothelial Dysfunction; Hemolysis; Fluid Overload

Keywords

Microcirculation; Cardiopulmonary bypass; Colloid oncotic pressure; Hemodilution; Hemolysis

Outcome Measures

Primary Outcomes (5)

• Perfused vessel density (PVD, mm mm-²)

  reflecting microcirculatory diffusion capacity

  Timepoint 1: 5-10 min after induction of anesthesia

• Perfused vessel density (PVD, mm mm-²)

  reflecting microcirculatory diffusion capacity

  Timepoint 2: 5-10 min after aortic cross clamping

• Perfused vessel density (PVD, mm mm-²)

  reflecting microcirculatory diffusion capacity

  Timepoint 3: 5-10 min after weaning from cardiopulmonary bypass

• Perfused vessel density (PVD, mm mm-²)

  reflecting microcirculatory diffusion capacity

  Timepoint 4: 15-30 min after arrival on the intensive care unit

• Perfused vessel density (PVD, mm mm-²)

  reflecting microcirculatory diffusion capacity

  Timepoint 5: twenty four (24) hours after arrival on the intensive care unit

Secondary Outcomes (15)

• Colloid oncotic pressure (COP, mmHg)

  T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.

• albumin (g L-¹)

  T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.

• hemolysis index (H-index)

  T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.

• haptoglobin (g L-¹)

  T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.

• NO consumption (μmol L-¹)

  T1, 5-10 min after induction of anesthesia; T2, 5-10 min after aortic cross clamping; T3, 5-10 min after weaning from cardiopulmonary bypass; T4, 15-30 min after arrival on the intensive care unit; T5, 24 hours after arrival on the intensive care unit.

Other Outcomes (35)

• Age

  Preoperative

• Gender

  Preoperative

• Body Surface area (BSA)

  Preoperative

Study Arms (2)

T (Treatment)

ACTIVE COMPARATOR

The most optimal prime fluid from part I (based on the effect on perfused vessel density) + additional albumin during cardiopulmonary bypass.

Drug: Treatment: additional albumin during cardiopulmonary bypass

C (control)

SHAM COMPARATOR

The most optimal prime fluid from part I (based on the effect on perfused vessel density) + additional ringers during cardiopulmonary bypass.

Drug: control: additional ringers during cardiopulmonary bypass

Interventions

Treatment: additional albumin during cardiopulmonary bypass DRUG

Treatment group (T): administration of 100 mL Human Albumin (20%), first dose directly after aortic cross clamping and blood cardioplegia administration, second dose after the third blood cardioplegia administration (± 30 min after the first dose).

T (Treatment)

control: additional ringers during cardiopulmonary bypass DRUG

Control group (C): administration of 100 mL of Ringer's solution, first dose directly after aortic cross clamping and blood cardioplegia administration, second dose after the third blood cardioplegia administration (± 30 min after the first dose).

C (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects
• Informed consent
• Elective coronary artery bypass surgery with cardiopulmonary bypass

You may not qualify if:

• Emergency operations
• Re-operation
• Elective thoracic aortic surgery
• Elective valve surgery
• Combined procedure CABG and valve surgery
• Known allergy for human albumin or gelofusine

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC, AMC location

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Hemolysis; Edema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• A.B.A. Vonk, MD, PhD

  Cardiothoracic surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A.M. Beukers, MD

CONTACT

020-4444444; a.beukers@amsterdamumc.nl

A.B.A. Vonk, MD PhD

CONTACT

020-4444444

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Single blind, masked to observer
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiothoracic surgeon, Principle Investigator, doctor

Model Details: In two consecutive randomized controlled trials, we study the effect of prime fluid strategies on perfused vessel density (part I) and the effect of additional albumin during cardiopulmonary bypass compared with ringers on perfused vessel density (part II). In this study part (II), the effect of additional albumin during cardiopulmonary bypass compared with ringers on perfused vessel density.

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 12, 2022
• Study Start: October 15, 2023
• Primary Completion: July 15, 2024
• Study Completion: January 15, 2025
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Upon request

Locations

NL (1)