Kidney Function in Diabetics During CPB (Cardio Pulmonary... | NCT03405532

Studies
Kidney Function in Diabetics During CPB (Cardio Pulmonary Bypass)

NCT03405532

Sponsor

Sahlgrenska University Hospital

Status

Suspended

Last Update Posted

Apr 23, 2024Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Diabetes Mellitus, Kidney, CPB

Interventions

DM-ECC

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not enough eligible patients leading to slow recruitment

Expanded Access Info

Start Date

Jan 11, 2018Actual

Primary Completion Date

Jan 2030Estimated

Completion Date

Jan 2030Estimated

First Submitted Date

Jan 5, 2018

First Submission Date that Met QC Criteria

Jan 19, 2018

First Posted Date

Jan 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2024

Last Update Posted Date

Apr 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
DM-ECC	Diagnostic Test	Diabetes mellitus CPB

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with diabetes mellitus undergoing surgery requiring CBP.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sven-Erik Ricksten, Prof	Sahlgrenska Universitetssjukhuset	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital		Gothenburg			Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided