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NCT05739604 Clinical Trial

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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05739604
Other study ID # NKBBN/575/2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 19, 2020
Est. completion date December 15, 2022

Study information
Verified date February 2023
Source Medical University of Gdansk
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date December 15, 2022
Est. primary completion date September 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood sample analysis
The concentrations of AAs and related compounds were determined by liquid chromatography/mass spectrometry (LC/MS)

Locations
Country Name City State
Poland Medical University of Gdansk - Departament of Anesthesiology and Intensive Care Gdansk Pomorskie

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) Daily analysis of concentrations of amino acids (AA) and related compounds with usage of liquid chromatography/mass spectrometry (LC/MS). Through study completion, an average of 1 year
Secondary Comparison the free amino acids (FAA) profile of survivors and nonsurvivors Daily analysis of concentrations of amino acids (AA) and related compounds with usage of liquid chromatography/mass spectrometry (LC/MS). Through study completion, an average of 1 year
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