Consistency Between Measures of Renal Function in ICU Pat... | NCT05385094

Studies
Consistency Between Measures of Renal Function in ICU Patients

NCT05385094

Sponsor

Karolinska University Hospital

Status

Unknown status

Last Update Posted

May 23, 2022Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Critical Illness

Interventions

S Creatinine concentration
Serum Cystatin C concentration
Urinary Creatinine Clearance

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

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2006Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Dec 12, 2021

First Submission Date that Met QC Criteria

May 19, 2022

First Posted Date

May 23, 2022Actual

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

May 19, 2022

Last Update Posted Date

May 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johan Petersson, Associate Profesor, Senior Consultant, Karolinska University HospitalPrincipal Investigator

Lead Sponsor

Karolinska University HospitalOTHER

Collaborators

Not provided

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

This study aim to compare different measures of renal function (glomerular filtration rate) in ICU patients.

Detailed Description

The study uses a large dataset of prospectively collected data according to clinical routines.

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

5,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S Creatinine concentration	Diagnostic Test
Serum Cystatin C concentration	Diagnostic Test
Urinary Creatinine Clearance	Diagnostic Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlations between estimates of renal function		7 days
Correlations between changes in estimates of renal function		7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICU patients with at least one measurement of urinary creatinine clearance

Exclusion Criteria:

Renal replacement therapy initiated before the measurement of creatinine clerance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

General ICU patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital Solna		Stockholm		17176	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

No plan.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided