Does pulsatile blood flow during cardiopulmonary bypass lead to a reduction in the average increase in postoperative creatinine levels in patients with preoperative renal dysfunction when compared to non-pulsatile blood flow?
ID
Source
Brief title
Condition
- Coronary artery disorders
- Renal disorders (excl nephropathies)
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The relative change in serum creatinine levels in the postoperative period
following cardiac surgery when compared to preoperative values. In particular,
an increase in postoperative creatinine levels of 26.5 *mol/L when compared to
preoperative creatinine values is considered as AKI.
Secondary outcome
Highest serum creatinine level measured in the first 72 postoperative hours
following surgery. Postoperative urine production, serum urea levels,
creatinine clearance, glomerular filtration rate, biomarkers for acute renal
injury, prevalence of postoperative renal replacement therapy, nadir oxygen
delivery (DO2), DO2/VCO2 ratio, sublingual microcirculatory perfused vessel
density and perfused boundary region, and sublingual oxygen saturation levels.
Background summary
In the Netherlands, about 14,000 patients yearly undergo cardiac surgery with
cardiopulmonary bypass (CPB), which might be associated with postoperative
complications like renal dysfunction/acute kidney injury. Previous studies
suggest that pulsatile blood flow during CPB has protective effects on the
renal function. In high-risk patients, pulsatile blood flow improved
microcirculatory and renal perfusion and reduced postoperative elevations in
creatinine in patients undergoing coronary artery bypass graft surgery. Others
however found no beneficial effects of pulsatile blood flow during CPB on
postoperative renal function. Due to the conflicting evidence we aim to
investigate whether pulsatile blood flow during CPB might be beneficial for
postoperative renal function. We hypothesize that pulsatile blood flow during
CPB reduces the relative increase in perioperative creatinine levels after
cardiac surgery in patients with preoperative renal dysfunction. We also aim to
investigate possible underlying mechanisms by focusing on the level of
microcirculatory perfusion and oxygenation, the delivery and consumption of
oxygen in the systemic circulation and CO2 production in patients subjected to
pulsatile or non-pulsatile flow.
Study objective
Does pulsatile blood flow during cardiopulmonary bypass lead to a reduction in
the average increase in postoperative creatinine levels in patients with
preoperative renal dysfunction when compared to non-pulsatile blood flow?
Study design
Randomized controlled multicenter trial
Intervention
Pulsatile flow during cardiopulmonary bypass
Study burden and risks
We hypothesize that pulsatile blood flow might be beneficial for perioperative
renal function, and therefore patients may benefit from inclusion in this study
group. The use of non-pulsatile or pulsatile blood flow is part of routine
cardiosurgical procedures and not associated with a risk for the patient.1 A
total of 120 ml of extra blood will be drawn from an existing intra-arterial
line while the patient is under anesthesia. The intra-arterial line is part of
routine clinical care in cardiac surgery, and will therefore not add up to
patient discomfort in the present study. Microscopic imaging or reflectance
spectroscopy of the microvasculature by means of the GlycoCheck or O2C is a
noninvasive measurement. DO2 and VCO2 levels are automatically recorded by an
integrated monitor in the heart-lung machine device.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Informed consent
- Adult subjects (age 18-90 years) undergoing elective cardiac surgery with cardiopulmonary bypass
- Patients with preoperative renal dysfunction (either eGFR <55 mL/min/1.73m2 at one measurement, or an eGFR <60 mL/min/1.73m2 for more than three months) or patients with diabetes mellitus and an eGFR <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)
- BSA > 2.3 m2
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL50135.029.14 |
| OMON | NL-OMON21086 |