Impact of CRRT on Serum Carnitine and Micronutrient Levels

NCT07467889 | Completed

• 1 other identifier: 2022/24
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the changes in blood levels of micronutrients and carnitine in critically ill patients with Acute Kidney Injury (AKI) who are undergoing Continuous Renal Replacement Therapy (CRRT). While CRRT is a life-saving intervention for managing metabolic disturbances and fluid overload in patients with Stage 2-3 AKI, it may also lead to the inadvertent removal of essential micronutrients (vitamins, trace elements, and amino acids) through the extracorporeal circuit. The research will prospectively compare 100 adult patients across two groups: those receiving CRRT and those managed without CRRT. Researchers will analyze blood samples and effluent fluid to determine the clearance rates and total losses of various substances, including carnitine, selenium, zinc, and various amino acids. By comparing levels at the first hour and 24th hour of intensive care admission, the study seeks to determine if CRRT significantly contributes to micronutrient deficiencies in this vulnerable population.

Conditions

Acute Kidney Injury (Nontraumatic); Critical Illness

Keywords

Acute Kidney Injury; Critical Illness; Continuous Renal Replacement Therapy (CRRT); Effluent Analysis

Outcome Measures

Primary Outcomes (1)

• Extracorporeal Clearance of Micronutrients and Carnitine

  Calculation of the clearance rates for trace elements (selenium, zinc, copper, iron), carnitine subforms, and 22 different amino acids by analyzing their concentrations in the blood and effluent (waste fluid) during the 24-hour Continuous Renal Replacement Therapy (CRRT) period.

  At the 24th hour of Continuous Renal Replacement Therapy (CRRT)

Secondary Outcomes (5)

• Changes in Serum Carnitine Concentrations

  Baseline (1st hour of admission) and 24 hours

• comparison of serum amino acid concentration

  first hour of intensive care unite admission and the 24th hour

• comparison of serum vitamins(B12,folat) concentrations

  first hour of intensive care admission and the 24 th hour

• The difference in micronutrient status between patients receiving and not receiving CRRT.

  24 hours after hospital admission/start of treatment.

• Clinical Correlation

  Through study completion (up to 24 hours)

Interventions

Continuous Renal Replacement Therapy (CRRT) PROCEDURE

atients receive CRRT in Continuous Veno-venous Hemodialysis (CVVHD) mode with a target dose of 30 mL/kg/hour. The procedure uses a polysulfone Ultraflux AV1000S filter with a surface area of 1.8 m2. Anticoagulation is provided with unfractionated heparin. Blood flow rate (Qb) is set between 100-140 mL/min, and dialysate flow rate (Qd) is adjusted to 30% of Qb to ensure optimal saturation

Standard of Care (Non-CRRT Management) OTHER

Patients with Stage 2-3 AKI who do not meet the criteria for CRRT or are managed with conservative medical therapy according to the attending clinician's decision. These patients receive routine ICU care without extracorporeal treatment.

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

The study population consists of adult patients (aged 18-90 years) admitted to a 36-bed general Intensive Care Unit (ICU) in a tertiary education and research hospital. The population focuses on patients diagnosed with Acute Kidney Injury (AKI) Stage 2 or 3 according to the KDIGO clinical practice guidelines. Participants are selected from patients who require an evaluation for Continuous Renal Replacement Therapy (CRRT) within the first hour of their ICU admission. The cohort includes a diverse range of critically ill patients, excluding those with end-stage chronic conditions or specific comorbidities that could confound the analysis of micronutrient clearance

You may qualify if:

• Patients aged 18-90 years
• Diagnosis of AKI Stage 2 or 3 according to KDIGO
• Evaluation for CRRT requirement within the first hour of ICU admission.

You may not qualify if:

• End-stage renal disease or history of chronic RRT
• AKI due to dialyzable toxins,Child-Pugh C liver cirrhosis
• Terminal malignancy,AKI secondary to cardiac arrest
• High risk of mortality within the first 24 hours
• Prior RRT for the current AKI episode,History of kidney transplantation
• Pregnancy or breastfeeding
• Lack of informed consent from the patient or legal representative.

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Gulhane Training and Research Hospital, Intensive Care Clinic

Ankara, keçiören, 06010, Turkey (Türkiye)

Location

Related Publications (3)

• Fah M, Van Althuis LE, Ohnuma T, Winthrop HM, Haines KL, Williams DGA, Krishnamoorthy V, Raghunathan K, Wischmeyer PE. Micronutrient deficiencies in critically ill patients receiving continuous renal replacement therapy. Clin Nutr ESPEN. 2022 Aug;50:247-254. doi: 10.1016/j.clnesp.2022.05.008. Epub 2022 May 23.

  PMID: 35871932 RESULT

• Koekkoek KWA, Berger MM. An update on essential micronutrients in critical illness. Curr Opin Crit Care. 2023 Aug 1;29(4):315-329. doi: 10.1097/MCC.0000000000001062. Epub 2023 Jun 8.

  PMID: 37306546 RESULT

• Berger MM, Shenkin A, Schweinlin A, Amrein K, Augsburger M, Biesalski HK, Bischoff SC, Casaer MP, Gundogan K, Lepp HL, de Man AME, Muscogiuri G, Pietka M, Pironi L, Rezzi S, Cuerda C. ESPEN micronutrient guideline. Clin Nutr. 2022 Jun;41(6):1357-1424. doi: 10.1016/j.clnu.2022.02.015. Epub 2022 Feb 26. Erratum In: Clin Nutr. 2024 Apr;43(4):1024. doi: 10.1016/j.clnu.2024.03.004.

  PMID: 35365361 RESULT

MeSH Terms

Conditions

Acute Kidney Injury; Critical Illness

Interventions

Continuous Renal Replacement Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensivist, Intensive Care Unit

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 12, 2026
• Study Start: January 1, 2023
• Primary Completion: March 15, 2025
• Study Completion: December 15, 2025
• Last Updated: March 16, 2026

Record last verified: 2023-02

Locations

TU (1)