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

NCT03373318 | Unknown Phase 4

• 1 other identifier: IIBSP-ALB-2017-72
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Incidence of DRA-ACC

  The incidence of DRA-ACC will be defined according to the KDIGO scale, for which the levels of plasma creatinine (mmol / L) will be determined. The KDIGO scale classify the injury or acute renal failure as stage I, II or III using as reference the creatinine levels.

  7 days

Study Arms (2)

Experimental

EXPERIMENTAL

Human Albumin

Drug: Human albumin

Control

ACTIVE COMPARATOR

Plasmalyte

Drug: Plasmalyte

Interventions

Human albumin DRUG

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

Experimental

Plasmalyte 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.

Control

Eligibility Criteria

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

You may qualify if:

• 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%

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Spanish Clinical Research Network - SCReN: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Serum Albumin, Human; Plasmalyte A

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Jordi Miralles, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi Miralles, MD

CONTACT

+34935537541; jmiralles@santpau.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 14, 2017
• Study Start: January 10, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

ES (1)