Influence of Albumin on Acute Renal Dysfunction Associated With Cardiac Surgery Under Extracorporeal Circulation

NCT ID: NCT03373318

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2019-08-31

Brief Summary

Acute renal dysfunction associated with cardiac surgery (DRA-ACC) in our hospital population affects 39% of patients, being an important cause of morbidity and mortality, increasing the need for dialysis and assuming a prolongation of stay in the unit of intensive care, as well as an increase in the economic cost.

In this sense, extracorporeal circulation (CPB) is a clear aggression for renal function due to multiple effects, not entirely known.

Human albumin is sometimes used as part of the priming of the CEC circuit in variable concentration according to published centers and studies, demonstrating benefits on the maintenance of plasma oncotic pressure during the period of ECC, as well as other effects that can protect renal function during this period of renal injury.

Despite the use of albumin in the ECC priming both in Spain and in other countries, there are currently no published studies demonstrating the effect of albumin on renal function administered during CPB in cardiac surgery during the postoperative period. with a high incidence of kidney injury, although there are current studies that confirm a decrease in the incidence of kidney injury in patients with hypoalbuminemia and who undergo heart surgery without extracorporeal circulation.

The hypothesis of this study is based on the potential protective effect of albumin on renal function in patients undergoing heart surgery under CPB, in which there is a high incidence of postoperative hypoalbuminemia.

This study aims to obtain information about the effect that albumin can have in this population of patients with a high incidence of acute renal dysfunction, and if this benefit exists, whether it is significant or not to justify its systematic use.

Detailed Description

This study is aimed to analyze the effect of the use of human albumin during ECC on the incidence of ARD-ACC in patients undergoing cardiac surgery with CPB diagnosed according to the KDIGO scale during the first 7 days after the intervention.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental

Human Albumin

Group Type: EXPERIMENTAL

Human albumin

Intervention Type: DRUG

Single dose as a primer for the CEC, in sufficient quantity to reach a concentration of 4% of the total volume of priming.

Control

Plasmalyte

Group Type: ACTIVE_COMPARATOR

Plasmalyte

Intervention Type: DRUG

The dose and the speed of administration depend on the age, weight, clinical and biological status of the patient and the concomitant treatment. The recommended dose for adults, the elderly and adolescents: from 500 ml to 3 liters / 24 hours.

Interventions

Human albumin

Single dose as a primer for the CEC, in sufficient quantity to reach a concentration of 4% of the total volume of priming.

Intervention Type: DRUG

Plasmalyte

The dose and the speed of administration depend on the age, weight, clinical and biological status of the patient and the concomitant treatment. The recommended dose for adults, the elderly and adolescents: from 500 ml to 3 liters / 24 hours.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients (> 18 years) scheduled for cardiopulmonary bypass surgery with Glomerular Filtration Rate (GFR) greater than or equal to 60 and left ventricular ejection fraction greater than or equal to 40%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Clinical Research Network - SCReN

NETWORK

Sponsor Role: collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jordi Miralles, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Jordi Miralles, MD

Role: CONTACT

jmiralles@santpau.cat

+34935537541

Facility Contacts

Jordi Miralles, MD

Role: primary

jmiralles@santpau.cat

+34935537541

Other Identifiers

IIBSP-ALB-2017-72

Identifier Type: -

Identifier Source: org_study_id