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Completed

NCT Number: NCT04599569

Influence of Renal Replacement TherApy on Indirect Calorimetry

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Leipzig

Leipzig, Saxony, D-04103, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indirect calorimetry

Device

indirect calorimetry with and without renal replacement therapy

Primary outcomes

  1. energy expenditure

    Time frame: 60 minutes

    energy expenditure in kcal/d

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

Influence of Renal Replacement TherApy on Indirect Calorimetry: a Prospective Observational Study

Acronym: IRATIC

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2020
Registry last updated
Dec 20, 2024

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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