Kidney Failure, Renal Insufficiency
Conditions
Keywords
amino acid, continuous renal replacement therapy, effluent loss
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.
Interventions
None listed
Sponsors
Karolinska Institutet
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Austria
Contacts
Primary ContactSarah Yadavalli, Dr.
Backup ContactArabella Fischer, Dr.
Outcome results
None listed