Influence of Renal Replacement TherApy on Indirect Calorimetry (IRATIC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Renal Failure; Mechanical Ventilation
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Sirak Petros, MD; Phone Number: +49 341 9712700; Email: sirak.petros@medizin.uni-leipzig.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, D-04103
      • Recruiting
      • University Hospital of Leipzig
      • Contact: Sirak Petros, MD; Phone Number: ++49 3419712700; Email: sirak.petros@medizin.uni-leipzig.de
      • Contact: Lorenz Weidhase, MD; Phone Number: ++49 3419712480; Email: lorenz.weidhase@medizin.uni-leipzig.de
      • Sub-Investigator: Kevin Kunz, MD
      • Sub-Investigator: Frank Seidel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

critically ill mechanically ventilated medical patients requiring renal replacement therapy

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
energy expenditure	energy expenditure in kcal/d	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carbon dioxide elimination	Carbon dioxide elimination in ml/min	60 minutes
respiratory quotient	respiratory Quotient, defined as the Ratio of Carbon dioxide elimination to Oxygen consumption	60 minutes

Collaborators and Investigators

• Sponsor: University of Leipzig
• Investigators: Principal Investigator: Sirak Petros, MD, University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 18, 2020
• First Submitted That Met QC Criteria: October 18, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: energy expenditure; respiratory quotient; indirect calorimetry; renal replacement therapy; carbon dioxide elimination
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: IRATIC-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No