Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-27 @ 8:03 PM
Study NCT ID:
NCT06547892
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2024-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU
Sponsor:
Hospital do Coracao
Organization:
Study Overview
Official Title:
Use of Vasopressin in Patients at High Risk of Acute Kidney Injury Admitted to the ICU: a Feasibility Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOVA-AKI
Brief Summary:
Renal dysfunction is a frequent complication in patients admitted to intensive care units (ICUs), associated with high morbidity and mortality. Current therapeutic options to prevent this condition are limited and lack robust scientific evidence. This pilot study consists of a multicenter, blinded, randomized clinical trial, unprecedented in the literature to date, aiming to fill this knowledge gap and offer new therapeutic perspectives to improve renal outcomes in critically ill patients admitted to the ICU.
Detailed Description:
This is a multicenter, placebo-controlled, double-blind, randomized feasibility clinical trial with a proposal to include 60 patients across 3 to 4 research centers.
This study will be conducted in Brazilian hospitals, covering both public and private healthcare profiles across various states of Brazil. Most of these hospitals are academic and teaching institutions, ensuring a wide diversity of data and perspectives for the research.
The objective of this study is to assess the feasibility of conducting a larger subsequent trial to analyze whether the use of vasopressin in patients prone to developing acute kidney dysfunction after admission to intensive care units (ICUs) can prevent the condition (acute kidney dysfunction).
This study is based on the null hypothesis (H0) that there will be no significant difference in the development of acute kidney injury between the group treated with vasopressin and the control group, while the alternative hypothesis (H1) proposes that the administration of vasopressin may reduce the risk of acute kidney injury in high-risk patients admitted to ICUs. The primary objective is to evaluate the feasibility of the study, specifically adherence to the established protocol and the monitoring of potential adverse effects during its conduct.
This study will be conducted in Brazilian hospitals, covering both public and private healthcare profiles across various states of Brazil. Most of these hospitals are academic and teaching institutions, ensuring a wide diversity of data and perspectives for the research.
The objective of this study is to assess the feasibility of conducting a larger subsequent trial to analyze whether the use of vasopressin in patients prone to developing acute kidney dysfunction after admission to intensive care units (ICUs) can prevent the condition (acute kidney dysfunction).
This study is based on the null hypothesis (H0) that there will be no significant difference in the development of acute kidney injury between the group treated with vasopressin and the control group, while the alternative hypothesis (H1) proposes that the administration of vasopressin may reduce the risk of acute kidney injury in high-risk patients admitted to ICUs. The primary objective is to evaluate the feasibility of the study, specifically adherence to the established protocol and the monitoring of potential adverse effects during its conduct.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: