Diabetes Mellitus, Kidney, CPB Clinical Trial
— DM-ECCOfficial title:
The Effect of the CPB on Kidney Blood Flow, Function and Oxygen Uptake During Open Heart Surgery in Patients With Diabetes Mellitus
| Verified date | April 2024 |
| Source | Sahlgrenska University Hospital, Sweden |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Suspended |
| Enrollment | 30 |
| Est. completion date | January 2030 |
| Est. primary completion date | January 2030 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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: - |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Sahlgrenska University Hospital | Gothenburg |
| Lead Sponsor | Collaborator |
|---|---|
| Sahlgrenska University Hospital, Sweden |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Renal O2 extraction | Renal O2 extraction measured by sampling blood from a catheter inserted into the kidney vein. | 2 years | |
| Secondary | GFR | GFR (Glomerular filtration rate), measured with CrEDTA- and PAH- clearance. | 2 years | |
| Secondary | Renal blood flow | Change in renal blood flow measured by sampling blood from a catheter inserted into the kidney vein | 2 years |