Clinical trial NCT06659835: Amino Acid Loss During Continuous Renal Replacement Therapy
Official title: Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Insufficiency
Kidney Failure
Keywords: amino acid
continuous renal replacement therapy
effluent loss
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2024-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enroll 30 intensive care patients: 20 patients receiving continuous renal replacement therapy and 10 patients without renal replacement therapy. The study will be carried out at the Medical University of Vienna at a 16-bed intensive care unit admitting patients after cardiothoracic and major vascular surgery.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Amino acid effluent loss
timeFrame: CRRT start, day 4 of continuous renal replacement therapy
measure: Amino acid plasma concentration CRRT group
timeFrame: day 0, day 4 of continuous renal replacement therapy
measure: Amino acid plasma concentration non-CRRT group
timeFrame: preoperative day/enrollment to postoperative day 4
Secondary outcomes:
measure: Time course of effluent loss of amino acids over all measured time points
timeFrame: duration of continuous renal replacement therapy, maximum 30 days
measure: Time course of plasma concentration of amino acids over all measured time points
timeFrame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Urine concentration of amino acids over treatment period
timeFrame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Nitrogen balance
timeFrame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Blood urea nitrogen
timeFrame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Creatinine
timeFrame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Albumin
timeFrame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Total protein
timeFrame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Vitamins
timeFrame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Trace elements
timeFrame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Indirect Calorimetry
timeFrame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Bioimpedance analysis
timeFrame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Ultrasound Muscle and Adipose Tissue Thickness
timeFrame: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Muscle Strength
timeFrame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Mobility
timeFrame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days
measure: Duration of Continuous Renal Replacement Therapy
timeFrame: duration of Continuous Renal Replacement Therapy (CRRT group), through study completion on average 10 days
measure: Length of stay
timeFrame: length of ICU and hospital stay, through study completion maximum 1 year
measure: Mortality
timeFrame: length of ICU and hospital stay, through study completion maximum 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Sarah Yadavalli, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Arabella Fischer, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Andrea Laßnigg, Prof.
role: STUDY_DIRECTOR
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