Clinical Trials Logo

Clinical Trial Summary

Colloid solutions are widely used for volume replacement therapy because of their high oncotic pressure, which could reduce interstitial fluid shifting. Human albumin is the only colloid solution of biologic origin with a molecular weight of 60 kDa. As the most abundant plasma protein, it has physiological importance in the well-being of the endothelial glycocalyx. Older studies in septic patients, however, did not show any benefit of albumin over saline solution. Crystalloid solutions, such as Ringer's acetate, do not impair neither renal function nor coagulation, but their volume expanding effect is questionable. For several reasons (use of heart-lung machine, systemic inflammation, coagulation disturbances), patients undergoing cardiac surgery need especially large amounts of fluids. However, there are no large trials comparing albumin solutions to crystalloid solutions cardiac surgery. This double-blinded trial will randomize according to a power analysis 1250 cardiac surgery patients (=625+625) at Meilahti hospital to use either 4% Albumin or Ringer's acetate solutions for both priming of the heart-lung machine and perioperative volume replacement therapy. The primary efficacy and safety endpoint of this study is the incidence of major adverse events (MAE), defined as a composite endpoint of all-cause mortality, acute myocardial infarction, acute heart failure or low output syndrome, resternotomy, stroke, certain arrhythmias, major bleeding, infections compromising post-procedural rehabilitation, acute kidney injury within 90 days postoperatively. The secondary outcomes are total number of MAEs, major adverse cardiac events (MACE), perioperative fluid balance, blood product transfusions, blood loss, acute kidney injury, days alive without mechanical ventilation/outside ICU/at home in 90 days as well as 90-day mortality. Blood samples for biochemical analyses will be collected at four perioperative time points. This trial will provide data about efficacy and safety of 4% albumin in cardiac surgery patients. The biochemical mechanisms of albumin will be assessed.


Clinical Trial Description

The use of cardiopulmonary bypass (CPB) between two study solutions: albumin solution with the final concentration of 4% and Ringer's acetate solution. The trial consists of two phases as follows. For each patient, one and the same study solution will used in both phases of the trial according to randomization. In the first phase of the trial, the study solution will be used for priming of the CPB tubing. The CPB priming volume comprises only of the study solution. See the Blinding section below for more details. - Albumin group (trial group): A mixture of 20% (200 mg/mL) albumin solution (Albuman® 200 g/L, Sanquin, the Netherlands) with Ringer's acetate solution (see below) in the final albumin concentration of 4%. - Ringer group (conventional group): Ringer's acetate solution (Ringer-acetate®, Baxter; pH 6.0, contents Na+ 131 mmol/L, Cl- 112 mmol/L, acetate 30 mmol/L) alone. In the second phase of the trial, during surgery and the first 24 hours of ICU treatment, study solution will be used up to 3200 mL for volume replacement therapy. Ringer's acetate solution is used thereafter, i.e. if more than 3200 mL are needed for volume replacement therapy during the second study phase. The volume replacement therapy is not protocolled but will be based on the clinical decision. Albumin group (trial group):4% (40 mg/mL) albumin(Albuman®, Sanquin, the Netherlands) •Ringer group (conventional group): Ringer's acetate solution (Ringer-acetate®, Baxter; pH 6.0, contents Na+ 131 mmol/L, Cl- 112 mmol/L, acetate 30 mmol/L) The trial will end after the first 24 hours of ICU treatment or when the patient leaves the ICU if the latter occurs within the first postoperative 24 hours. After the study period, fluids are administered according to the local clinical practice. The use of blood products, excluding albumin, is not protocolled, but will be based on the clinical decision. For physiological basic need of fluid, Ringer's acetate solution will be given throughout the study period, i.e. during surgery and postoperatively, as a background infusion of 0.5 ml/kg/h, rounded to the nearest multible of 10 ml. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02560519
Study type Interventional
Source Helsinki University Central Hospital
Contact
Status Completed
Phase Phase 4
Start date March 21, 2017
Completion date November 4, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT02908009 - A Case Control Study to Identify the Role of Epigenetic Regulation of Genes Responsible for Energy Metabolism and Mitochondrial Function in the Obesity Paradox in Cardiac Surgery
Completed NCT01998438 - Prospective Trial of Tranexamic Acid in Cardiac Surgery Phase 4
Completed NCT01805466 - Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO) N/A
Completed NCT02658006 - Evaluation of Monitoring TECHNOlogies in the PERI-OPerative Care of Cardiac Surgical Patients N/A
Completed NCT02571920 - Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA) N/A
Completed NCT02267538 - Dexmedetomidine and Delirium in Patients After Cardiac Surgery Phase 4
Completed NCT02866825 - Studying Complement Inhibition in Complex Cardiac Surgery Phase 2
Completed NCT02513862 - Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery N/A
Recruiting NCT03884725 - Fibrinogen Concentrate In Children Cardiac Surgery 2 Phase 4
Recruiting NCT01879475 - Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery N/A
Completed NCT00598195 - Ketamine Pharmacokinetics in Children Having Heart Surgery N/A
Completed NCT02972684 - Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass N/A
Recruiting NCT02560285 - High-risk Patients in Cardiac Surgery Procedures: HiriSCORE N/A
Terminated NCT02793895 - Detection of Atrial Fibrillation After Cardiac Surgery N/A
Active, not recruiting NCT03343418 - Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery Phase 4
Recruiting NCT03469440 - Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery N/A
Recruiting NCT03882593 - Blood Cell Adhesion to Arterial Filters During Cardiac Surgery
Withdrawn NCT02119806 - Decreasing the Incidence of Delirium After Cardiac Surgery Phase 4
Completed NCT02831907 - Portal Flow Pulsatility as a Risk Factor for Acute Kidney Injury After Cardiac Surgery N/A
Recruiting NCT02745951 - HELIox CardiOPlegia Trial During Cardiac surgERy N/A