Medical University of Vienna
Vienna, State of Vienna, 1090, Austria
Location status: Recruiting
Location contact
Arabella Fischer, Dr.
CONTACT
Arabella Fischer, Dr.
PRINCIPAL_INVESTIGATOR
Sarah Yadavalli, Dr.
CONTACT
NCT Number: NCT06659835
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Vienna, State of Vienna, 1090, Austria
Location status: Recruiting
Arabella Fischer, Dr.
CONTACT
Arabella Fischer, Dr.
PRINCIPAL_INVESTIGATOR
Sarah Yadavalli, Dr.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A) CRRT group:
B)Non-CRRT group:
Exclusion criteria
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
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
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
Time frame: duration of continuous renal replacement therapy, maximum 30 days
Time course of effluent loss 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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: duration of Continuous Renal Replacement Therapy (CRRT group), through study completion on average 10 days
duration of Continuous Renal Replacement Therapy
Time frame: length of ICU and hospital stay, through study completion maximum 1 year
Length of ICU stay
Time frame: length of ICU and hospital stay, through study completion maximum 1 year
mortality during ICU and hospital stay
Contact information is provided by the study sponsor or research team.
Arabella Fischer, Dr.
CONTACT
Sarah Yadavalli, Dr.
CONTACT
Medical University of Vienna
Other
Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study
Acronym: DIAMINO
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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