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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Human albumin; Drug: Plasmalyte

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Jordi Miralles, MD; Phone Number: +34935537541; Email: jmiralles@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Exclusion Criteria:

• Patients who do not meet the inclusion criteria and those who have a history of allergic reactions to human albumin, as well as those who have received iodinated contrast during the 7 days prior to surgery and pregnant women, will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; Human Albumin	Drug: 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.
ACTIVE_COMPARATOR: Control; Plasmalyte	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Spanish Clinical Research Network - SCReN
• Investigators: Principal Investigator: Jordi Miralles, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2018
• Primary Completion (ANTICIPATED): August 1, 2019
• Study Completion (ANTICIPATED): August 1, 2019

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (ACTUAL): December 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: IIBSP-ALB-2017-72

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No