Amino Acid Supplementation in Continuous Renal Replacement Therapy

NCT06835816 | Recruiting

• 1 other identifier: 2023-07570-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Balance of amino acids

  Total balance of amino acid losses and supplementation given

  After 3 days of dialysis

Secondary Outcomes (2)

• Amino acid concentration in plasma

  After 3 days of dialysis

• Concentration of vitamins and trace elements

  After 3 days of dialysis

Study Arms (1)

All patients

EXPERIMENTAL

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)

Interventions

Amino acid supplementation (Glavamin, Fresenius Kabi) DIETARY_SUPPLEMENT

Mixture of amino acids (67 g / 500 ml) given intravenously

All patients

Eligibility Criteria

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

You may qualify if:

• Dialysis where amino acid supplementation is planned by treating physician

You may not qualify if:

• Liver failure
• Muscle disease
• Neurodegenerative disease

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jonathan Grip, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Grip, MD, PhD

CONTACT

+46736230906; jonathan.grip@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: February 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

SE (1)