search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Renal function after pulsatile blood flow during cardiopulmonary bypass in cardiac surgery


- candidate number19631
- NTR NumberNTR4832
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-okt-2014
- Secondary IDsNL50135.029.14 CCH 14-01
- Public TitleRenal function after pulsatile blood flow during cardiopulmonary bypass in cardiac surgery
- Scientific TitleRenal function after pulsatile blood flow during cardiopulmonary bypass in cardiac surgery
- ACRONYMREPULS
- hypothesisPulsatile blood flow during CPB reduces the relative increase in perioperative creatinine levels after cardiac surgery in patients with preoperative renal dysfunction
- Healt Condition(s) or Problem(s) studiedCardiac surgery, Kidney fuction, Cardiopulmonary Bypass (CPB)
- Inclusion criteriaAdult 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)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-okt-2014
- planned closingdate30-sep-2016
- Target number of participants294
- InterventionsPatients 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.
- Primary outcomeRelative change in serum creatinine levels in postoperative period
- Secondary outcomePostoperative 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
- TimepointsT0= 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.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Christa Boer
- CONTACT for SCIENTIFIC QUERIESDr. Christa Boer
- Sponsor/Initiator VU University Medical Center, University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD6-okt-2014 - 29-okt-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl