No registrations found.
ID
Source
Brief title
Health condition
Cardiac surgery; Renal function; Cardiopulmonary bypass;
Sponsors and support
UMCG
Intervention
Outcome measures
Primary outcome
Relative change in serum creatinine levels in postoperative period
Secondary outcome
Postoperative urine production in ml;
Serum urea levels, creatinine clearance, glomerular filtration rate;
Nadir DO2, DO2/VCO2 ratio;
Sublingual microcirculatory perfused vessel density and perfused boundary region (n=40);
Microcirculatory and tissue oxygenation O2C levels (n=40);
Prevalence of renal replacement therapy
Study objective
Pulsatile blood flow during CPB reduces the relative increase in perioperative creatinine levels after cardiac surgery in patients with preoperative renal dysfunction
Study design
T0= blood + urine sample
T1= blood sample + buccal hemoglobin oxygenation
T2 = hemoglobin + microciculatory measurements
T3= hemoglobin + microciculatory measurements+ buccal hemoglobin oxygenation
T4 = blood + urine sample + microciculatory measurements+ buccal hemoglobin oxygenation
T5 = blood + urine sample + microciculatory measurements
T6 = blood + urine sample + microciculatory measurements+ buccal hemoglobin oxygenation
T7 = blood + urine sample.
Intervention
Patients will be randomly assigned to the following study groups:
- non-pulsatile bloodflow during CPB
- pulsatile bloodflow during CPB
Microcirculatory perfusion will be measured sublingually with an SDF camera. Buccal hemoglobin oxygenation will be measured with reflectance spectrophotometry. Extra blood will be drawn from an existing radial artery catheter. Urine samples will be gathered.
DO2/VO2/VCO2 values are measured with the heartlink monitor.
Christa Boer
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443830
c.boer@vumc.nl
Christa Boer
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443830
c.boer@vumc.nl
Inclusion criteria
Adult subjects with written informed consent (age 18-90 years) undergoing elective cardiac surgery with cardiopulmonary bypass; Patients with preoperative renal dysfunction (GFR <50 mL/min/1.73m2) or patients with diabetes mellitus and a GFR <60 mL/min/1.73m2 based on the CKD-EPI formula.
Exclusion criteria
- Emergency operations;
- Patients with previous heart surgery;
- Renal failure requiring preoperative renal replacement therapy (RRT)
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4680 |
| NTR-old | NTR4832 |
| CCMO | NL50135.029.14 |
| OMON | NL-OMON47075 |