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

NCT06681415 | Completed Phase 4

• 1 other identifier: PaulsStradins
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Pleural Effusions Post Coronary Artery Bypass Graft; Hypoxia; Hypoalbuminemia

Keywords

Pleural effusion following cardiopulmonary bypass

Outcome Measures

Primary Outcomes (2)

• Pleural effusion (centimetres) in thoracic CT images and calculated in millilitres.

  Thorax CT scans were performed on all patients on the first postoperative day, with subsequent image analysis conducted by a single radiologist. The radiologist measured pleural effusion size (cm).

  Thorax CT scans were performed on all patients on the first postoperative day.

• Pleural effusion in thoracic CT images and calculated in millilitres.

  Thorax CT scans were performed on all patients on the first postoperative day, with subsequent image analysis conducted by a single radiologist. The investigators calculated effusion volume (ml).

  Thorax CT scans were performed on all patients on the first postoperative day.

Study Arms (2)

Albumin group

EXPERIMENTAL

The standard CPB priming volume of 1050 ml, comprising isochloremic solution Deltajonin® and 250 ml of 15% Mannitol, was used. The study group replaced 100 ml of Deltajonin® solution with 100 ml of 20% human albumin.

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

No-albumin group

NO INTERVENTION

The standard CPB priming volume of 1050 ml, comprising isochloremic solution Deltajonin® and 250 ml of 15% Mannitol

Interventions

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

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.

Albumin group

Eligibility Criteria

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

You may qualify if:

• Individuals scheduled for elective open-heart surgeries, encompassing procedures such as ascending aorta surgery, coronary artery bypass grafting, and heart valve replacement or repair, either independently or in combination, without the use of hypothermic circulatory arrest.

You may not qualify if:

• reduced left ventricular ejection fraction (EF \< 50%),
• chronic kidney disease,
• chronic lung disease,
• pre-existing anemia,
• pathological chest X-ray findings before surgery.

Sponsors & Collaborators

• Pauls Stradins Clinical University Hospital: lead
• Riga Stradins University: collaborator

Study Sites (1)

Pauls Stradiņš Clinical University Hospital

Riga, LV1002, Latvia

Location

MeSH Terms

Conditions

Hypoxia; Hypoalbuminemia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Eva Strike, MD, PhD

  Head of the cardiac anesthesiology and ICU department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 8, 2024
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)