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Influence of Renal Replacement TherApy on Indirect Calorimetry

NCT ID: NCT04599569

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Renal Failure Mechanical Ventilation

Keywords

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indirect calorimetry energy expenditure carbon dioxide elimination renal replacement therapy respiratory quotient

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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indirect calorimetry

indirect calorimetry with and without renal replacement therapy

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Sirak Petros, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sirak Petros, MD

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Locations

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University Hospital of Leipzig

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

References

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Knoll A, Petros S, Pasieka B, Weidhase L. Influence of kidney replacement therapy on indirect calorimetry in critically ill patients. Eur J Clin Nutr. 2025 Jul 30. doi: 10.1038/s41430-025-01643-9. Online ahead of print.

Reference Type DERIVED
PMID: 40739037 (View on PubMed)

Other Identifiers

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IRATIC-2020

Identifier Type: -

Identifier Source: org_study_id