Perfusion - Pressure - Creatinine Trial

NCT01408420 | Completed

• 1 other identifier: H-1-2009-1 13
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Acute Kidney Injury

Keywords

Renal insufficiency; Acute Kidney Injury; Postoperative; Extracorporeal Circulation; Heart surgery

Outcome Measures

Primary Outcomes (1)

• Glomerular Filtration Rate measured the day before surgery compared to 4 - 6 days and 4 months (+/- 14 days) postoperative

  Measured by means of Cr-EDTA clearance

  The day before surgery, 4 - 6 days and 4 months (+/- 14 days) postoperative

Secondary Outcomes (4)

• Renal oxygen consumption measured minutes before surgery compared to intraoperative, 6 hours postoperative and 8.00 a.m. the day after surgery

  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.

• 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

  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.

• 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

  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

• 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

  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

Study Arms (2)

Standard blood pressure

NO INTERVENTION

Extracorporeal circulation during the surgery are conducted using standard blood pressure

MAP > 60 mmHg

ACTIVE COMPARATOR

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

Interventions

MAP > 60 mmHg PROCEDURE

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

MAP > 60 mmHg

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 70
• Combined procedures (heart valve-, bypass- and aortic aneurysm surgery)

You may not qualify if:

• Age \< 70
• S-creatinine \> 200 µmol/L
• Acute operation
• Endocarditis

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Heart Foundation: collaborator

Study Sites (1)

Department of Cardiothoracic Surgery, Rigshospitalet

Copenhagen East, Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Kandler K, Nilsson JC, Oturai P, Jensen ME, Moller CH, Clemmesen JO, Arendrup HC, Steinbruchel DA. Higher arterial pressure during cardiopulmonary bypass may not reduce the risk of acute kidney injury. J Cardiothorac Surg. 2019 Jun 13;14(1):107. doi: 10.1186/s13019-019-0929-4.

  PMID: 31196131 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Daniel A Steinbrüchel, Professor

  Department of Cardiothoracic Surgery, Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMSc

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: August 3, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

DK (1)