Crystalloids vs Albumin Prime Solution and Postoperative Pulmonary Complications

NCT04839432 | Completed

• 1 other identifier: IRB 00012157
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In 2019, the investigators initiated a new priming fluid therapy strategy in the cardiopulmonary bypass (CPB) machine for patients undergoing pulmonary endarterectomy surgery. It consisted in a transition from a "pure" primarly balanced crystalloid priming fluid strategy to a 4% human albumin priming fluid-strategy in addition to a low volume of balanced crystalloid solution. The rationale was the theoritical assumption that albumin leads to better intravascular volume expansion compared to crystalloid and therefore could reduce overall volume requirement during surgery and consequently potentially decrease the incidence of postoperative pulmonary complications. The objective of this propensity-matched study was to evaluate the effectiveness of this intervention

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• pulmonary complications

  a composite of two pulmonary complications ( reperfusion lung syndrome and/or acute respiratory distress syndrome)

  postoperative day 7

Study Arms (2)

Crystalloids group

Patients had only a balanced crystalloid solution in the priming of the cardiopulmonary bypass (pre interventional group)

albumin group

Patients had only a 4% albumin solution in addtion to a very low volume of a balanced crystalloid solution in the priming of the cardiopulmonary bypass (post interventional group)

Behavioral: implementation of albumin solution in the priming of the cardiopulmonary bypass machine

Interventions

implementation of albumin solution in the priming of the cardiopulmonary bypass machine BEHAVIORAL

In March 2019, the investigators initiated a new priming fluid policy strategy aiming at replacing our traditional pure crystalloid fluid administration for an albumin one in order to decrease the relatively high-rate of observed pulmonary complications

albumin group

Eligibility Criteria

• Age: 14 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients undergoing pulmonary endarterectomy surgery from 2018 to 2019 ( a two years study period)

You may qualify if:

• All consecutive patients undergoing pulmonary endarterectomy surgery

You may not qualify if:

• Patients with important missing data
• Patients undergoing combined surgery
• Patients undergoing an emergency pulmonary endarterectomy surgery

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Marie lannelongue

Le Plessis-Robinson, Paris, 92350, France

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amelie Delaporte, MD

  Marie lannelongue

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

FR (1)