Renal function
Conditions
Interventions
Trade Name: Albutein 20%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN ALBUMIN
Other descriptive name: HUMAN ALBUMIN SOLUTION 20%
Concentration unit: g/l gram(s)/litre
Concentr
Sponsors
Institut de Recerca Hospital de la Santa Creu i Sant Pau
Eligibility
Sex/Gender
All
Inclusion 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% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Timepoint(s) of evaluation of this end point: 7 days;Secondary Objective: To analyze the perfusion pressures during cardiopulmonary bypass (CPB) in relation to the use of Albumin To analyze the balance of fluids administered during surgery. To analyze the amount of total bleeding and hemoglobin levels during the postoperative period (hospital stay). To analyze the transfusion requirements of blood products during the postoperative period (hospital stay). To analyze the requirements of vasoactive and inotropic drugs during the initial postoperative period (72 hours). To analyze the body weight of patients during the first 48 hours. To analyze plasma levels of albumin during the postoperative period. To compare the need for dialysis, the appearance of complications and the length of hospital stay in both groups. To analyze the mortality per month of patients undergoing cardiac surgery using CPB.;Primary end point(s): The main endpoint of the study will be the incidence of acute renal dysfunction associated with cardiac surgery (DRA-ACC) defined as the percentage of patients who develop DRA-ACC within 7 days after surgery. DRA-ACC will be defined according to the KDIGO scale, for which the levels of plasma creatinine (mmol / L) will be determined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Volume of total bleeding and hemoglobin levels during the postoperative period (hospital stay) in relation to the use of Albumin during CPB. -Needs of transfusion of blood products during the postoperative period (hospital stay) in relation to the use of Albumin during CPB. - Requirements for vasoactive and inotropic drugs during the initial postoperative period (72 hours) in relation to the use of Albumin during CPB. - Body weight of the patients during the first 48 hours in relation to the use of Albumin during CPB - Plasma levels of albumin during the postoperative period (hospital stay) in relation to the use of Albumin during CPB -Need of dialysis, incidence of postoperative complications, hospital stay. -Mortality per month of patients undergoing cardiac surgery by CPB in relation to the use of Albumin during CPB.;Timepoint(s) of evaluation of this end point: 48 hours, 72 hours and 1 month | — |
Countries
Spain
Contacts
Public ContactUICEC Sant Pau
Institut de Recerca Hospital de la Santa Creu i Sant Pau
Outcome results
None listed