Amino Acid Supplementation in Continuous Renal Replacement Therapy (AARRT)

February 14, 2025 updated by: Jonathan Grip, Karolinska University Hospital

ICU patients treated with continuous renal replacement therapy is recruited prior to start of treatment.

Blood samples are drawn and then dialysis start without amino acid supplementation. After a few hours samples are drawn from blood and dialysate. Then patients are given amino acid supplementation (33.5g/24hrs) for 20-24 hours. New samples are drawn and amino acid supplementation is increased to 67g/24hrs and new samples are drawn after additional 24 hours. Then CRRT will continue with the full amino acid supplementation (standars of care).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Dialysis where amino acid supplementation is planned by treating physician

Exclusion Criteria:

  • Liver failure
  • Muscle disease
  • Neurodegenerative disease

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All patients
All patients will start CRRT treatment without amino acid supplementation After a few hours samples are drawn from blood and dialysate Patients then receive low dose of supplementation for 24 hours (33.5g, 250 ml Glavamin, Fresenius Kabi) and new samples are drawn After that patients receive full supplementation (67g, 500 ml Glavamin, Fresenius Kabi) for the rest the of CRRT treatment. After 24 hours of this treatment new samples are drawn.
Dietary supplement: Amino acid supplementation (Glavamin, Fresenius Kabi)
Mixture of amino acids (67 g / 500 ml) given intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance of amino acids
Time Frame: After 3 days of dialysis
Total balance of amino acid losses and supplementation given
After 3 days of dialysis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amino acid concentration in plasma
Time Frame: After 3 days of dialysis
Concentration of various amino acids in plasma without and with supplementation
After 3 days of dialysis
Concentration of vitamins and trace elements
Time Frame: After 3 days of dialysis
Analysis of various trace elements and vitamins
After 3 days of dialysis

Collaborators and Investigators

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

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Jonathan Grip, MD, PhD, Karolinska University Hospital

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)

February 3, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-07570-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be availible per request

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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