Clinical trial NCT04599569: Influence of Renal Replacement TherApy on Indirect Calorimetry
Official title: Influence of Renal Replacement TherApy on Indirect Calorimetry: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Renal Failure
Mechanical Ventilation
Keywords: indirect calorimetry
energy expenditure
carbon dioxide elimination
renal replacement therapy
respiratory quotient
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critically ill mechanically ventilated medical patients requiring renal replacement therapy

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.

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.

Eligibility 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.

Primary outcomes:
measure: energy expenditure
timeFrame: 60 minutes
Secondary outcomes:
measure: Carbon dioxide elimination
timeFrame: 60 minutes
measure: respiratory quotient
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Hospital of Leipzig
state: Saxony
Study officials:
affiliation: University of Leipzig
name: Sirak Petros, MD
role: PRINCIPAL_INVESTIGATOR
References: