Perfusion - Pressure - Creatinine Trial (PPC)

This study has been completed.
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
Daniel Steinbruchel, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01408420
First received: July 19, 2011
Last updated: March 26, 2014
Last verified: March 2014
  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

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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: April 2011
Study Completion Date: March 2014
Primary Completion Date: January 2014 (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: MAP > 60 mmHg
A blood pressure of MAP > 60 mmHg is used during extracorporeal circulation. The higher MAP is maintained by using continuous intravenous administration of norepinephrine titrated to the appropriate dose for each patient.
Procedure: MAP > 60 mmHg
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408420

Locations
Denmark
Department of Cardiothoracic Surgery, Rigshospitalet
Copenhagen East, Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Heart Foundation
Investigators
Study Chair: Daniel A Steinbrüchel, Professor Department of Cardiothoracic Surgery, Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Daniel Steinbruchel, DMSc, 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: March 26, 2014
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
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 22, 2014