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

NCT05739604 | Completed

• 1 other identifier: NKBBN/575/2019
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Amino Acid Catabolism Disorder

Outcome Measures

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)

  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 Outcomes (1)

• Comparison the free amino acids (FAA) profile of survivors and nonsurvivors

  Through study completion, an average of 1 year

Study Arms (2)

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

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

Interventions

Blood sample analysis DIAGNOSTIC_TEST

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

Nonsurvivors; Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients hospitalized in ICU who met inclusion criteria.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdansk - Departament of Anesthesiology and Intensive Care

Gdansk, Pomeranian Voivodeship, 80-210, Poland

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Radosław Owczuk, Prof.

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of Department of Anaesthesiology and Intensive Care

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 22, 2023
• Study Start: June 19, 2020
• Primary Completion: September 10, 2022
• Study Completion: December 15, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)