Kidney Function in Diabetics During CPB (Cardio Pulmonary Bypass) (DM-ECC)

April 21, 2024 updated by: Maria Tholén, Sahlgrenska University Hospital, Sweden

The Effect of the CPB on Kidney Blood Flow, Function and Oxygen Uptake During Open Heart Surgery in Patients With Diabetes Mellitus

Filtration of urine in the kidney requires sufficient oxygen supply. The filtration of urine is greater in patents with diabetes. Our theory is that the diabetic kidney has a higher oxygen demand than the non diabetic kidney thereby making the diabetic kidney more sensitive to decreased oxygen delivery following reduced blood flow. With a catheter inserted into the kidney vein we will monitor the blood flow and oxygen saturation before and during CPB, in patient with diabetes.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with diabetes mellitus undergoing surgery requiring CBP.

Description

Inclusion Criteria:

  • Patients with diabetes mellitus
  • Serum creatinine < 150 micromol/L preoperative
  • Heart surgery requiring CPB
  • LV (left ventricle) EF >40 %
  • Normal hemoglobin

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal O2 extraction
Time Frame: 2 years
Renal O2 extraction measured by sampling blood from a catheter inserted into the kidney vein.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GFR
Time Frame: 2 years
GFR (Glomerular filtration rate), measured with CrEDTA- and PAH- clearance.
2 years
Renal blood flow
Time Frame: 2 years
Change in renal blood flow measured by sampling blood from a catheter inserted into the kidney vein
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Sven-Erik Ricksten, Prof, Sahlgrenska Universitetssjukhuset

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2018

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

January 5, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SahlgrenskaUHMT02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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