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Efficacy of 20% Human Albumin in Reducing Pleural Effusion After Cardiopulmonary Bypass

NCT06681415 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-11-08

No results posted yet for this study

Summary

Human albumin is a widely used additive in cardiopulmonary bypass all around the world, but its effect on various outcomes has been debated. The goal of this observational study is to compare the effect of 100 ml 20% human albumin addition to cardiopulmonary bypass on pleural effusion development after open heart surgery.

The main question it aims to answer is:

• Does albumin, in addition to cardiopulmonary bypass, reduce pleural effusion development after open heart surgery? Patients will go under elective open heart surgery. Investigators will compare pleural effusion volume on the first day after surgery between patients who received albumin and those who didn't.

Conditions

Interventions

DRUG

Adding 100ml of 20% human albumin to cardiopulmonary bypass priming solution

Adding albumin to the priming solution can help reduce hemodilution and consequent extracardiac complications by maintaining colloid oncotic pressure. Albumin helps counteract the intravascular fluid shift to the extravascular space and reduces the risk of complications associated with fluid imbalance. Postoperative pulmonary complications following CPB can significantly impact postoperative outcomes. Patients developing PPC have prolonged mechanical ventilation, extended hospitalisation, longer ICU stays, and elevated postoperative mortality. One of the most common PPCs following CPB is pleural effusion. Our primary objective was to evaluate the effectiveness of adding 100 ml of 20% human albumin to the CPB priming solution compared to standard priming, with a specific focus on its potential role in reducing the occurrence of pleural effusion.

Sponsors & Collaborators

  • Riga Stradins University

    collaborator OTHER

  • Pauls Stradins Clinical University Hospital

    lead OTHER

Principal Investigators

  • Eva Strike, MD, PhD · Head of the cardiac anesthesiology and ICU department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-12-01
Completion
2024-01-01

Countries

  • Latvia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06681415 on ClinicalTrials.gov