Perfusion - Pressure - Creatinine Trial (PPC)
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Purpose
In Denmark around 3500 procedures are conducted involving a heart-lung-machine per year. An increase in the prevalence of postoperative kidney insufficiency have been observed following these procedures, during the last years. Kidney related complications are associated with a higher mortality and morbidity.
The reason and mechanisms behind this impaired kidney function is unknown. One possible cause could be that the blood pressure used in the heart-lung-machine is too low, during surgery. In the PPC trial we plan to include 100 patients. One half of the patients are operated with a normal, lower, blood pressure on the heart-lung-machine. The other half receives a blood pressure of > 60 mmHg during surgery.
The primary goal of the trial is to measure the kidney function (GFR) the day before surgery compared to day 4 - 6 and 4 months (+/- 14 days) after surgery. During the surgery a catheter is inserted through the femoral vein into the kidney vein. This makes it possible to measure several biochemical markers and the oxygen consumption of the kidney, during the surgery. Urine samples are also collected and analyzed.
The study hypothesis:
The glomerular filtration rate (GFR) is better preserved after cardiac surgery with extra corporal circulation with an intended increased periprocedural arterial blood pressure compared to current practice.
| Condition | Intervention |
|---|---|
|
Acute Kidney Injury |
Procedure: MAP > 60 mmHg during extracorporeal circulation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Impact of Perfusion Pressure During Extracorporeal Circulation on Postoperative Kidney Function |
- Glomerular Filtration Rate measured the day before surgery compared to 4 - 6 days and 4 months (+/- 14 days) postoperative [ Time Frame: The day before surgery, 4 - 6 days and 4 months (+/- 14 days) postoperative ] [ Designated as safety issue: Yes ]Measured by means of Cr-EDTA clearance
- Renal oxygen consumption measured minutes before surgery compared to intraoperative, 6 hours postoperative and 8.00 a.m. the day after surgery [ Time Frame: Directly after placement of the renal vein catheter and every 15 minutes during surgery. 6 hours after surgery and 8.00 a.m. the day after surgery. ] [ Designated as safety issue: Yes ]Measured as difference in saturation of blood gas measurements from the renal vein catheter and radial artery.
- neutrophil gelatinase-associated lipocalin (NGAL) measured just before anaesthesia compared to just after extracorporal perfusion has ended, 6 hours postoperatively, 8.00 a.m. the day after surgery, 2nd and 5th day [ Time Frame: Before induction of anaesthesia in the operating room, directly after the extracorporeal perfusion has ended. 6 hours postoperative. 8.00 a.m. the day after surgery. 2nd and 5th day postoperative. ] [ Designated as safety issue: No ]Measured in urine samples
- Renal renin and proANP excretion measured the day before surgery compared to just after induction of anaesthesia, directly after extracorporeal perfusion has begun, just before extracorporeal perfusion ends, 1st and 5th postoperative day [ Time Frame: The day before surgery. Directly after induction of anaesthesia. Directly after extracorporeal perfusion has begun. Just before extra corporeal perfusion is ended.1st and 5th day postoperative ] [ Designated as safety issue: Yes ]Measured from the renal vein catheter and venous blood sample
- Serum Cystatin C measured the day before surgery compared to directly after induction of anaesthesia, directly after extracorporeal perfusion has begun, just before extra corporeal perfusion has ended, 1st and 5th day postoperative [ Time Frame: The day before surgery. Directly after induction of anaesthesia. Directly after extracorporeal perfusion has begun. Just before extra corporeal perfusion has ended.1st and 5th day postoperative ] [ Designated as safety issue: No ]Measured from standard blood sample.
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Standard blood pressure
Extracorporeal circulation during the surgery are conducted using standard blood pressure
|
|
|
Active Comparator: High blood pressure
A blood pressure of MAP > 60 mmHg is used during extracorporeal circulation.
|
Procedure: MAP > 60 mmHg during extracorporeal circulation
During heart surgery a blood pressure with a MAP > 60 mmHg during extracorporeal circulation is used.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 70
- Combined procedures (heart valve-, bypass- and aortic aneurysm surgery)
Exclusion Criteria:
- Age < 70
- S-creatinine > 200 µmol/L
- Acute operation
- Endocarditis
Contacts and Locations| Contact: Kristian Kandler, MD | +4553571977 | kristiankandler@gmail.com |
| Denmark | |
| Department of Cardiothoracic Surgery, Rigshospitalet | Recruiting |
| Copenhagen East, Copenhagen, Denmark, 2100 | |
| Contact: Kristian Kandler, MD +4553571977 kristiankandler@gmail.com | |
| Study Chair: | Daniel A Steinbrüchel, Professor | Department of Cardiothoracic Surgery, Rigshospitalet, Denmark |
More Information
No publications provided
| Responsible Party: | Kristian Kandler, Department of Cardiothoracic Surgery, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01408420 History of Changes |
| Other Study ID Numbers: | H-1-2009-1 13 |
| Study First Received: | July 19, 2011 |
| Last Updated: | August 2, 2011 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by Rigshospitalet, Denmark:
|
Renal insufficiency Acute Kidney Injury Postoperative Extracorporeal Circulation Heart surgery |
Additional relevant MeSH terms:
|
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013