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Influence of Renal Replacement TherApy on Indirect Calorimetry (IRATIC)

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ClinicalTrials.gov Identifier: NCT04599569
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Sirak Petros, MD, University of Leipzig

Study Description
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Brief Summary:
Renal replacement therapy may affect carbon dioxide elimination, which may theoretically influence measurement of energy expenditure by means of indirect calorimetry. However, available clinical studies are noct conclusive on this issue. This observational study aims to investigate the effect of renal replacement therapy on indirect calorimetry in critically ill mechanically ventilated patients.

Condition or disease Intervention/treatment
Acute Renal Failure Mechanical Ventilation Device: indirect calorimetry

Detailed Description:

Optimal Nutrition of the critically ill is still a clinical challenge. Current guidelines recommend that measurement of energy expenditure using indirect calorimetry should be favoured in critically ill patients. The technique is based on measurement of oxygen consumption and carbon dioxide elimination. Experimental studies have reported on carbon dioxide elimination via renal replacement therapy. Since acute kidney injury with requirement for renal replacement therapy (RRT) is common in the intensive care unit, the significance of carbon dioxide elimination via the dialyser should be clarified. However, available evidence from clinical studies is contradictory, one reason being the heterogenous study design.

In this prospective observational study on critically ill mechanically ventilated medical patients requiring RRT, indirect calorimetry (IC) will be conducted twice on the same day with and without RRT: either immediately before commencement of RRT followed by a second IC with RRT after an RRT run time of an hour, or immediately before the end of an RRT session followed by a second IC an hour after the termination of RRT.

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Renal Replacement TherApy on Indirect Calorimetry: a Prospective Observational Study
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: indirect calorimetry
    indirect calorimetry with and without renal replacement therapy

Outcome Measures
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Primary Outcome Measures :
  1. energy expenditure [ Time Frame: 60 minutes ]
    energy expenditure in kcal/d


Secondary Outcome Measures :
  1. Carbon dioxide elimination [ Time Frame: 60 minutes ]
    Carbon dioxide elimination in ml/min

  2. respiratory quotient [ Time Frame: 60 minutes ]
    respiratory Quotient, defined as the Ratio of Carbon dioxide elimination to Oxygen consumption


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
critically ill mechanically ventilated medical patients requiring renal replacement therapy
Criteria

Inclusion Criteria:

  • simultaneous requirement for mechanical ventilation and renal replacement therapy
  • informed consent

Exclusion Criteria:

  • age <18 years
  • requirement for therapeutic hypothermia
  • serum lactate >4 mmol/l
  • requirement for inspiratory oxygen fraction >0.6 and positive end-expiratory pressure >12 mbar
  • leak in the ventilator circuit (e.g. due to a chest tube)
  • requirement for extracorporeal circulatory support
  • refusal to participate in the study.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599569


Contacts
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Contact: Sirak Petros, MD +49 341 9712700 sirak.petros@medizin.uni-leipzig.de

Locations
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Germany
University Hospital of Leipzig Recruiting
Leipzig, Saxony, Germany, D-04103
Contact: Sirak Petros, MD    3419712700 ext ++49    sirak.petros@medizin.uni-leipzig.de   
Contact: Lorenz Weidhase, MD    3419712480 ext ++49    lorenz.weidhase@medizin.uni-leipzig.de   
Sub-Investigator: Kevin Kunz, MD         
Sub-Investigator: Frank Seidel, MD         
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Sirak Petros, MD University of Leipzig
More Information
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Responsible Party: Sirak Petros, MD, Professor, University of Leipzig
ClinicalTrials.gov Identifier: NCT04599569    
Other Study ID Numbers: IRATIC-2020
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sirak Petros, MD, University of Leipzig:
indirect calorimetry
energy expenditure
carbon dioxide elimination
renal replacement therapy
respiratory quotient
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases