Risk Factors for Acute Kidney Injury in Critically Ill Pa... | NCT04525625

Studies
Risk Factors for Acute Kidney Injury in Critically Ill Patients With Acute-on-Chronic Liver Failure

NCT04525625

Sponsor

Institutul Clinic Fundeni

Status

Unknown status

Last Update Posted

Feb 15, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Acute Kidney Injury
Acute-On-Chronic Liver Failure

Interventions

Not provided

Countries

Romania

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Sep 1, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Aug 21, 2020

First Submission Date that Met QC Criteria

Aug 21, 2020

First Posted Date

Aug 25, 2020Actual

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

Feb 14, 2023

Last Update Posted Date

Feb 15, 2023Actual

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

Acute kidney injury (AKI) is one of the most important factors associated with increased mortality in patients with acute-on-chronic liver failure (AoCLF). Early identification and treatment of this subgroup of patients may improve survival and decrease ICU length of stay. As kidney ischemia is one of the main mechanisms responsible for AKI in AoCLF, an increase in urinary to arterial partial pressure of oxygen may help in the early diagnosis of renal failure. For this arterial and urinary oxygen pressure will be measured at ICU admission, on day 1 and day 3 of ICU stay. Diagnosis of AKI within the first 28 days after ICU admission will be recorded

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AKI	incidence (%) of AKI in patients with AoCLF as defined by Acute Kidney Injury Network guidelines	28 days after ICU admission

Secondary Outcomes

Measure	Description	Time Frame
arterial to urinary oxygen gradient	mathematical difference in oxygen partial pressure between arterial blood and urine (mmHg) in patients with AKI compared to patients without AKI	ICU admission, ICU day 1 and ICU dy 3
mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- patients admitted to the ICU for acute-on-chronic liver failure

Exclusion Criteria:

pre-existing renal disease
urine output<200 mL/day
death within the first 24 hours after ICU admission
emergency liver transplantation within the follow-up period (28 days)

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

All consecutive patients admitted to a general ICU for ACLF who fall into the inclusion and exclusion criteria. Standard treatment will be applied to all patients and no supplemental intervention is required for the present study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dana Tomescu, Prof	Contact	0040722300288		danatomescu@gmail.com
Mihai Popescu, Assoc Prof	Contact			mihai.popescu@umfcd.ro

Overall Officials

Name	Affiliation	Role
Dana Tomescu, Prof	Fundeni Clinical Institute	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Popescu Mihai	Recruiting	Bucharest		022328	Romania

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury
D065290	Acute-On-Chronic Liver Failure

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided