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

• ClinicalTrials.gov Identifier: NCT03373318
• Recruitment Status: Unknown
• First Posted: December 14, 2017
• Last Update Posted: January 25, 2018
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborator: Spanish Clinical Research Network - SCReN
• Information provided by (Responsible Party): Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Kidney Injury	Drug: Human albumin; Drug: Plasmalyte	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Influence of Albumin on the Development of Acute Renal Dysfunction Associated With Cardiac Surgery Under Extracorporeal Circulation
• Actual Study Start Date: January 10, 2018
• Estimated Primary Completion Date: August 2019
• Estimated Study Completion Date: August 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Incidence of DRA-ACC [ Time Frame: 7 days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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%

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.

Contacts and Locations

Contacts

Contact: Jordi Miralles, MD; +34935537541; jmiralles@santpau.cat

Locations

Spain

Hospital de la Santa Creu i Sant Pau; Recruiting

Barcelona, Spain, 08025

Contact: Jordi Miralles, MD +34935537541 jmiralles@santpau.cat

Sponsors and Collaborators

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

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

More Information

• Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• ClinicalTrials.gov Identifier: NCT03373318
• Other Study ID Numbers: IIBSP-ALB-2017-72
• First Posted: December 14, 2017
• Last Update Posted: January 25, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Acute Kidney Injury; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Plasma-lyte 148; Ophthalmic Solutions; Pharmaceutical Solutions