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NCT Number: NCT06659835

Amino Acid Loss During Continuous Renal Replacement Therapy

The goal of this observational study is to learn about amino acid loss during continuous renal replacement therapy and plasma amino acid levels in intensive care patients. The main questions it aims to answer are:

What amount of amino acids is lost over the duration of continuous renal replacement therapy? How do amino acid plasma concentrations change over time in patients with and without continuous renal replacement therapy?

Amino acid concentrations will be measured in the effluent and in the plasma of patients receiving continuous renal replacement therapy as part of their regular medical care. In addition, plasma concentrations of amino acids will be studied in patients without renal replacement therapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Arabella Fischer, Dr.

CONTACT

[email protected]

Arabella Fischer, Dr.

PRINCIPAL_INVESTIGATOR

Sarah Yadavalli, Dr.

CONTACT

[email protected]

+43 067761632558

About this study

In order to quantify the amount of amino acids lost via the continuous renal replacement (CRRT) machine, it is warranted to measure amino acid concentrations in the blood and effluent over the entire treatment period.

To this end, 20 intensive care patients will be examined throughout the entire duration of CRRT as part of this exploratory non-interventional study. Additionally, 10 intensive care patients without renal replacement therapy will be enrolled. In the CRRT-group amino acid loss through the effluent will be measured at different time points. Amino acid plasma concentrations will be determined in both groups. Amino acid urine concentration, nitrogen balance, as well as blood urea nitrogen, creatinine and albumin in the plasma will be measured as secondary outcome parameters. Additionally, observations regarding nutritional status and mobility (indirect calorimetry, bioimpedance analysis, ultrasound muscle and adipose tissue thickness, strength and mobility scoring) will be analyzed as exploratory secondary outcomes.

Duration of CRRT, length of intensive care and hospital stay as well as mortality will be monitored.

High-performance liquid chromatography fluorescence as well as liquid chromatography-mass spectrometry will be performed to measure amino acid concentrations in plasma, effluent and urine.

To answer the primary research question, change in amino acid plasma concentrations and effluent loss between treatment start and day 4 of continuous renal replacement therapy will be analysed using a two-sided Wilcoxon signed rank test.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Postoperative ICU patients
  • Age ≥ 18 years
  • Patients on enteral or/and parenteral nutrition given according to internal standard operating procedure

A) CRRT group:

  • CRRT treatment planned; all types of CRRT (continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemodiafiltration (CVVHDF), continuous veno-venous hemofiltration (CVVH))

B)Non-CRRT group:

  • no current or previous (<30 days) continuous or intermittent RRT
  • no chronic kidney disease stage G3-G5

Exclusion criteria

  • Preoperative intensive care patients
  • Patients with liver cirrhosis stage 1-3 according to the Child-Pugh classification
  • Patients with acute liver failure

Treatment and study plan

Primary outcomes

  1. Amino acid effluent loss

    Time frame: CRRT start, day 4 of continuous renal replacement therapy

    Change of effluent loss of amino acids from start of continuous renal replacement therapy to day 4

  2. Amino acid plasma concentration CRRT group

    Time frame: day 0, day 4 of continuous renal replacement therapy

    Change of plasma concentration of amino acids from start of continuous renal replacement therapy to day 4

  3. Amino acid plasma concentration non-CRRT group

    Time frame: preoperative day/enrollment to postoperative day 4

    Change of plasma concentration of amino acids from the preoperative day to postoperative day 4 or to the last measurement at the intensive care unit, whichever is earlier

Secondary outcomes

  1. Time course of effluent loss of amino acids over all measured time points

    Time frame: duration of continuous renal replacement therapy, maximum 30 days

    Time course of effluent loss of amino acids over all measured time points

  2. Time course of plasma concentration of amino acids over all measured time points

    Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    Time course of plasma concentration of amino acids over all measured time points

  3. Urine concentration of amino acids over treatment period

    Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    Urine concentration of amino acids over treatment period

  4. Nitrogen balance

    Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    Nitrogen balance over treatment period

  5. Blood urea nitrogen

    Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    Blood urea nitrogen over treatment period

  6. Creatinine

    Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    Creatinine in blood, effluent, urine over treatment period

  7. Albumin

    Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    Albumin in blood, effluent, urine over treatment period

  8. Total protein

    Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    Total protein in blood, effluent urine over treatment period

  9. Vitamins

    Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    Vitamins (Vitamin B12, folate) in blood, effluent, urine over treatment period

  10. Trace elements

    Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    Trace elements (iron, iodide) in blood, effluent, urine over treatment period

  11. Indirect Calorimetry

    Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    Indirect calorimetry over treatment period

  12. Bioimpedance analysis

    Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    Bioimpedance analysis over treatment period

  13. Ultrasound Muscle and Adipose Tissue Thickness

    Time frame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    ultrasound to measure muscle and adipose tissue thickness over treatment period

  14. Muscle Strength

    Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    muscle strength assessment (Medical Research Council Scale for Muscle Strength) over treatment period

  15. Mobility

    Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days

    mobility assessment (Surgical Intensive Care Unit Optimal Mobilisation Score) over treatment period

  16. Duration of Continuous Renal Replacement Therapy

    Time frame: duration of Continuous Renal Replacement Therapy (CRRT group), through study completion on average 10 days

    duration of Continuous Renal Replacement Therapy

  17. Length of stay

    Time frame: length of ICU and hospital stay, through study completion maximum 1 year

    Length of ICU stay

  18. Mortality

    Time frame: length of ICU and hospital stay, through study completion maximum 1 year

    mortality during ICU and hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Arabella Fischer, Dr.

CONTACT

[email protected]

Sarah Yadavalli, Dr.

CONTACT

[email protected]

+43 67761632558

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study

Acronym: DIAMINO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2024
Registry last updated
May 25, 2025

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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