Amino Acid Loss During Continuous Renal Replacement Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Postoperative ICU patients
Age ≥ 18 years
Patients on enteral or/and parenteral nutrition given according to internal standard operating procedure
no current or previous (<30 days) continuous or intermittent RRT
Disqualifiers
Preoperative intensive care patients
Patients with liver cirrhosis stage 1-3 according to the Child-Pugh classification
Patients with acute liver failure
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 2 trial groupsGroup A: CRRT group
Group B: non-CRRT group
Trial outcomes
Primary outcomes
1
Amino acid effluent loss
Change of effluent loss of amino acids from start of continuous renal replacement therapy to day 4
Time frame
CRRT start, day 4 of continuous renal replacement therapy2
Amino acid plasma concentration CRRT group
Change of plasma concentration of amino acids from start of continuous renal replacement therapy to day 4
Time frame
day 0, day 4 of continuous renal replacement therapy3
Amino acid plasma concentration non-CRRT group
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
preoperative day/enrollment to postoperative day 4Secondary outcomes
1
Time course of effluent loss of amino acids over all measured time points
Time course of effluent loss of amino acids over all measured time points
Time frame
duration of continuous renal replacement therapy, maximum 30 days2
Time course of plasma concentration of amino acids over all measured time points
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 days3
Urine concentration of amino acids over treatment period
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 days4
Nitrogen balance
Nitrogen balance over treatment period
Time frame
duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 daysSponsors and contacts
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Medical University of Vienna
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov