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Completed

NCT Number: NCT05739604

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

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.

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Key information

Conditions

Sepsis Amino Acid Catabolism Disorder Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Gdansk - Departament of Anesthesiology and Intensive Care

Gdansk, Pomeranian Voivodeship, 80-210, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample analysis

Diagnostic Test

The concentrations of AAs and related compounds were determined by liquid chromatography/mass spectrometry (LC/MS)

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 22, 2023
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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