Amino Acid Loss During Continuous Renal Replacement Therapy
- Conditions
- Renal InsufficiencyKidney Failure
- Registration Number
- NCT06659835
- Lead Sponsor
- Medical University of Vienna
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amino acid effluent loss 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
Amino acid plasma concentration CRRT group 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
Amino acid plasma concentration non-CRRT group 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 Outcome Measures
Name Time Method Time course of effluent loss of amino acids over all measured time points duration of continuous renal replacement therapy, maximum 30 days Time course of effluent loss of amino acids over all measured time points
Time course of plasma concentration of amino acids over all measured time points 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
Urine concentration of amino acids over treatment period 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
Nitrogen balance duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days Nitrogen balance over treatment period
Blood urea nitrogen 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
Creatinine 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
Albumin 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
Total protein 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
Vitamins 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
Trace elements 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
Indirect Calorimetry duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days Indirect calorimetry over treatment period
Bioimpedance analysis 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
Ultrasound Muscle and Adipose Tissue Thickness 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
Muscle Strength 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
Mobility 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
Duration of Continuous Renal Replacement Therapy duration of Continuous Renal Replacement Therapy (CRRT group), through study completion on average 10 days duration of Continuous Renal Replacement Therapy
Length of stay length of ICU and hospital stay, through study completion maximum 1 year Length of ICU stay
Mortality length of ICU and hospital stay, through study completion maximum 1 year mortality during ICU and hospital stay
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria