Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525623
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Initial Resuscitation for Acute Kidney Injury in Cirrhosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Initial Resuscitation for Acute Kidney Injury in Patients With Cirrhosis A Pilot Randomized Trial Using a Volume Assessment Guidance Algorithm
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAKI-VAGA
Brief Summary:
The goal of this interventional study is to evaluate two strategies for how to provide intravenous IV fluids for treating patients with acute kidney injury AKI in cirrhosis The main question it aims to answer is what is the safety efficacy and feasibility of providing a recommendation to use a Volume Assessment Guidance Algorithm VAGA or give standard of care doses of IV albumin
Patients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation
Patients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation
Detailed Description:
This randomized open-label pilot feasibility trial will assess a volume assessment guidance algorithm VAGA in patients with AKI and cirrhosis Eligible patients must have AKI and decompensated cirrhosis In addition to assessing the adherence to the suggested guidance this study will measure the effect of the study intervention on grams of albumin given clinical efficacy outcomes AKI response rates survival RRT status transplant status and safety
Patients who meet eligibility criteria will be randomized 11 where the treating clinicians will receive a one-time recommendation for volume resuscitation using the VAGA or standard of care IV albumin repletion 1 gkgday for two days Both groups will be followed with assessments at 48 hours after randomization hospital discharge and 90-days after randomization
The primary efficacy outcome grams of albumin will be measured at 48 hours after randomization Primary secondary efficacy outcomes grams of albumin AKI response will be assessed at time of hospital discharge If a patient undergoes liver transplantation or initiation of RRT during the admission this will serve as a censoring date for these outcomes and relevant data will be collected at the time of the first of these events
The primary feasibility outcome is adherence to the suggested guidance assessed at 48 hours after randomization The VAGA group will receive one of three potential clinical recommendations a no further volume resuscitation b resuscitation with crystalloid or c resuscitation with colloid
This study will prospectively enroll approximately 50 adult patients at a single center
Patients who meet eligibility criteria will be randomized 11 where the treating clinicians will receive a one-time recommendation for volume resuscitation using the VAGA or standard of care IV albumin repletion 1 gkgday for two days Both groups will be followed with assessments at 48 hours after randomization hospital discharge and 90-days after randomization
The primary efficacy outcome grams of albumin will be measured at 48 hours after randomization Primary secondary efficacy outcomes grams of albumin AKI response will be assessed at time of hospital discharge If a patient undergoes liver transplantation or initiation of RRT during the admission this will serve as a censoring date for these outcomes and relevant data will be collected at the time of the first of these events
The primary feasibility outcome is adherence to the suggested guidance assessed at 48 hours after randomization The VAGA group will receive one of three potential clinical recommendations a no further volume resuscitation b resuscitation with crystalloid or c resuscitation with colloid
This study will prospectively enroll approximately 50 adult patients at a single center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None