coagulation status, colloid oncotic pressure (COP) and ion- and acid-base balance.
Conditions
Interventions
Trade Name: Tetraspan ®
Pharmaceutical Form: Solution for infusion
CAS Number: 8000006-02-2
Other descriptive name: STARCH POTATO
Trade Name: Volulyte®
Pharmaceutical Form: Solution for infusion
CAS
Sponsors
UZ Brussels
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients undergoing cardiac surgery with cardiopulmonary bypass. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Patients with preoperative, renal failure, urgent and redo operations, IABP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does the use of two different balanced hydroxyethyl starch solutions, influence the coagulation profile, acid-base status, ionogram, colloid oncotic pressure?;Secondary Objective: Safety profile and outcome;Primary end point(s): Coagulation profile, acid-base status, ionogram, colloid oncotic pressure.;Timepoint(s) of evaluation of this end point: Induction of anesthesia, on CBP, after CBP and POD1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Organ function and outcome.;Timepoint(s) of evaluation of this end point: POD1 | — |
Countries
Belgium
Contacts
Public ContactPerfusion
UZ Brussel
Outcome results
None listed