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Recruiting NCT06659835

Amino Acid Loss During Continuous Renal Replacement Therapy

— Observational Renal Insufficiency Kidney Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Renal Insufficiency, Kidney Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study

Overview

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.

Primary outcome measures

  • Amino acid effluent loss [Time frame: CRRT start, day 4 of continuous renal replacement therapy]
  • Amino acid plasma concentration CRRT group [Time frame: day 0, day 4 of continuous renal replacement therapy]
  • Amino acid plasma concentration non-CRRT group [Time frame: preoperative day/enrollment to postoperative day 4]
Secondary outcome measures (12)
  • Time course of effluent loss of amino acids over all measured time points [Time frame: duration of continuous renal replacement therapy, 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: preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days]
  • Nitrogen balance [Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days]
  • Blood urea nitrogen [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 [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 [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 [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]
  • Vitamins [Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days]
  • Trace elements [Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days]
  • Indirect Calorimetry [Time frame: duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days]
  • Bioimpedance analysis [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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Medical University of Vienna — Vienna

Publications

  • Maxvold NJ, Smoyer WE, Custer JR, Bunchman TE. Amino acid loss and nitrogen balance in critically ill children with acute renal failure: a prospective comparison between classic hemofiltration and hemofiltration with dialysis. Crit Care Med. 2000 Apr;28(4):1161-5. doi: 10.1097/00003246-200004000-00041. PMID 10809299
  • Kihara M, Ikeda Y, Fujita H, Miura M, Masumori S, Tamura K, Yabana M, Takagi N, Umemura S, Ishii M. Amino acid losses and nitrogen balance during slow diurnal hemodialysis in critically ill patients with renal failure. Intensive Care Med. 1997 Jan;23(1):110-3. doi: 10.1007/s001340050299. PMID 9037649
  • Berger MM, Shenkin A, Revelly JP, Roberts E, Cayeux MC, Baines M, Chiolero RL. Copper, selenium, zinc, and thiamine balances during continuous venovenous hemodiafiltration in critically ill patients. Am J Clin Nutr. 2004 Aug;80(2):410-6. doi: 10.1093/ajcn/80.2.410. PMID 15277163
  • Stapel SN, de Boer RJ, Thoral PJ, Vervloet MG, Girbes ARJ, Oudemans-van Straaten HM. Amino Acid Loss during Continuous Venovenous Hemofiltration in Critically Ill Patients. Blood Purif. 2019;48(4):321-329. doi: 10.1159/000500998. Epub 2019 Jul 10. PMID 31291614
  • Story DA, Ronco C, Bellomo R. Trace element and vitamin concentrations and losses in critically ill patients treated with continuous venovenous hemofiltration. Crit Care Med. 1999 Jan;27(1):220-3. doi: 10.1097/00003246-199901000-00057. PMID 9934919
  • Sundstrom Rehal M, Liebau F, Tjader I, Norberg A, Rooyackers O, Wernerman J. A supplemental intravenous amino acid infusion sustains a positive protein balance for 24 hours in critically ill patients. Crit Care. 2017 Dec 6;21(1):298. doi: 10.1186/s13054-017-1892-x. PMID 29212550
  • Bellomo R, Tan HK, Bhonagiri S, Gopal I, Seacombe J, Daskalakis M, Boyce N. High protein intake during continuous hemodiafiltration: impact on amino acids and nitrogen balance. Int J Artif Organs. 2002 Apr;25(4):261-8. doi: 10.1177/039139880202500403. PMID 12027135
  • Chua HR, Bellomo R. Nutritional Management of Patients Treated with Continuous Renal Replacement Therapy. Elsevier Inc.; 2013. https://doi.org/10.1016/B978-0-12-391934-2.00037-0

Identifiers

NCT: NCT06659835 · 2149/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗