Serum Free Amino Acid Concentrations in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)

Completed

• Conditions: Sepsis; Amino Acid Catabolism Disorder
• Interventions: Diagnostic Test: Blood sample analysis

• Registration Number: NCT05739604
• Lead Sponsor: Medical University of Gdansk

Brief Summary

Sepsis is a life-threatening condition associated with high morbidity and mortality. The breakdown of proteins mainly from skeletal muscles leads to the release of free amino acids (FAAs). The serum FAA pool has been repeatedly assessed and found to be significantly altered in patients with sepsis/septic shock. Sepsis is well known to be the most common factor contributing to the development of acute kidney injury in critically ill patients.

The investigators want to establish the baseline profile of FAAs and their derivatives in patients with sepsis/septic shock undergoing continuous renal replacement therapy due to sepsis-associated acute kidney injury. Secondly, the investigators want to compare the FAA profiles of the survivors and nonsurvivors.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-19
• Primary Completion: 2022-09-10
• Study Completion: 2022-12-15
• Status Verified: 2023-02
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• over 18 years of age
• present AKI
• requiring renal replacement therapy
• hospitalized at the ICU.

Exclusion Criteria

• acute kidney disease requiring renal replacement therapy prior to admission to the ICU
• chronic kidney disease requiring renal replacement therapy prior to admission to the ICU
• history of past CRRT.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nonsurvivors	Blood sample analysis	Patients hospitalized in the Department of Anaesthesiology and Intensive Care with sepsis or septic shock, undergoing continuous renal replacement therapy due to acute kidney injury, in whom the outcome of treatment was fatal.
Survivors	Blood sample analysis	Patients hospitalized in the Department of Anaesthesiology and Intensive Care with sepsis or septic shock, undergoing continuous renal replacement therapy due to acute kidney injury, in whom the outcome of treatment was survival.

Primary Outcome Measures

Name	Time	Method
Evaluation the baseline profile of FAAs and their derivatives in serum in a group of patients undergoing continuous renal replacement therapy (CRRT) due to sepsis associated acute kidney injury (SA-AKI) in the Intensive care unit (ICU)	Through study completion, an average of 1 year	Daily analysis of concentrations of amino acids (AA) and related compounds with usage of liquid chromatography/mass spectrometry (LC/MS).

Secondary Outcome Measures

Name	Time	Method
Comparison the free amino acids (FAA) profile of survivors and nonsurvivors	Through study completion, an average of 1 year	Daily analysis of concentrations of amino acids (AA) and related compounds with usage of liquid chromatography/mass spectrometry (LC/MS).

Trial Locations

Locations (1)

Medical University of Gdansk - Departament of Anesthesiology and Intensive Care; 🇵🇱 Gdańsk, Pomorskie, Poland