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Perfusion - Pressure - Creatinine Trial

NCT01408420 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-03-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

MAP > 60 mmHg

During heart surgery a blood pressure with a MAP \> 60 mmHg during extracorporeal circulation is used.

Sponsors & Collaborators

  • Danish Heart Foundation

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Daniel A Steinbrüchel, Professor · Department of Cardiothoracic Surgery, Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-01-31
Completion
2014-03-31

Countries

  • Denmark

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01408420 on ClinicalTrials.gov