Clinical trial NCT03373318: Influence of Albumin on Acute Renal Dysfunction Associated With Cardiac Surgery Under Extracorporeal Circulation
Official title: Influence of Albumin on the Development of Acute Renal Dysfunction Associated With Cardiac Surgery Under Extracorporeal Circulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Kidney Injury
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Spanish Clinical Research Network - SCReN
First posted: 2017-12-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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%

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.

Primary outcomes:
measure: Incidence of DRA-ACC
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Jordi Miralles, MD
role: PRINCIPAL_INVESTIGATOR
References: