Diabetes Mellitus, Kidney, CPBDM-ECCNCT03405532
Kidney Function in Diabetics During CPB (Cardio Pulmonary Bypass)
An observational study of Diabetes Mellitus, Kidney, CPB, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Kidney, CPB
- What is being tested?
- DM-ECC
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 11 Jan 2018to Jan 2030
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diabetes mellitus undergoing surgery requiring CBP.
Who may be able to join
- Patients with diabetes mellitus
- Serum creatinine < 150 micromol/L preoperative
- Heart surgery requiring CPB
- LV (left ventricle) EF >40 %
- Normal hemoglobin
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Kidney, CPB
- Being tested
- DM-ECC
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM-ECCDiagnostic test
Diabetes mellitus CPB
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal O2 extraction
Renal O2 extraction measured by sampling blood from a catheter inserted into the kidney vein.
Measured: 2 years
Secondary outcomes (2)
GFR
GFR (Glomerular filtration rate), measured with CrEDTA- and PAH- clearance.
Measured: 2 years
Renal blood flow
Change in renal blood flow measured by sampling blood from a catheter inserted into the kidney vein
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start11 Jan 2018
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Why it stopped: Not enough eligible patients leading to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Kidney, CPBStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Tholén, Sahlgrenska University Hospital
- Investigators
- Sven-Erik Ricksten, Prof, Principal investigator, Sahlgrenska Universitetssjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405532
- Sponsor's protocol ID
- SahlgrenskaUHMT02
- Acronym
- DM-ECC
- Status last verified
- Apr 2024
- First submitted
- 5 Jan 2018
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the CPB on Kidney Blood Flow, Function and Oxygen Uptake During Open Heart Surgery in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03405532
- Acronym / sponsor ID
- DM-ECC / SahlgrenskaUHMT02
- Conditions
- Diabetes Mellitus, Kidney, CPB
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Not enough eligible patients leading to slow recruitment
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diabetes mellitus undergoing surgery requiring CBP.
Key inclusion criteria (5 listed)
- Patients with diabetes mellitus
- Serum creatinine < 150 micromol/L preoperative
- Heart surgery requiring CPB
- LV (left ventricle) EF >40 %
- Normal hemoglobin
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DM-ECCDiabetes mellitus CPB | Diagnostic test | – |
Primary outcome
Renal O2 extraction
Time frame: 2 years
Renal O2 extraction measured by sampling blood from a catheter inserted into the kidney vein.
2 secondary outcomes
GFR
Time frame: 2 years
Renal blood flow
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven-Erik Ricksten, Prof principal investigator
Sahlgrenska Universitetssjukhuset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Kidney, CPB, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal O2 extraction (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.