Influence of Renal Replacement TherApy on Indirect Calorimetry

Mechanical Ventilation Clinical Trial

— IRATIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04599569
• Other study ID #: IRATIC-2020
• Status: Recruiting
• Start date: October 20, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: University of Leipzig
• Contact: Sirak Petros, MD
• Phone: +49 341 9712700
• Email: sirak.petros[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Mechanical Ventilation

Intervention

Device:
• indirect calorimetry
indirect calorimetry with and without renal replacement therapy

Locations

Country	Name	City	State
Germany	University Hospital of Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	energy expenditure	energy expenditure in kcal/d	60 minutes
Secondary	Carbon dioxide elimination	Carbon dioxide elimination in ml/min	60 minutes
Secondary	respiratory quotient	respiratory Quotient, defined as the Ratio of Carbon dioxide elimination to Oxygen consumption	60 minutes