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

February 20, 2023 updated by: Radosław Owczuk, Medical University of Gdansk

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-210
        • Medical University of Gdansk - Departament of Anesthesiology and Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients hospitalized in ICU who met inclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Survivors
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.
Diagnostic test: Blood sample analysis
The concentrations of AAs and related compounds were determined by liquid chromatography/mass spectrometry (LC/MS)
Nonsurvivors
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.
Diagnostic test: Blood sample analysis
The concentrations of AAs and related compounds were determined by liquid chromatography/mass spectrometry (LC/MS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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).
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison the free amino acids (FAA) profile of survivors and nonsurvivors
Time Frame: 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).
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

  • Principal Investigator: Radosław Owczuk, Prof., Medical University of Gdańsk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2020

Primary Completion (Actual)

September 10, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Estimate)

February 22, 2023

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKBBN/575/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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