IRATIC: Influence of Renal Replacement TherApy on Indirect Calorimetry

• Sponsor: University of Leipzig (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04599569
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 32.3
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Renal Failure; Mechanical Ventilation	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 Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Influence of Renal Replacement TherApy on Indirect Calorimetry: a Prospective Observational Study
• Actual Study Start Date: Oct 20, 2020
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Outcome Measures

Primary Outcome Measures

1. energy expenditure [60 minutes]

   energy expenditure in kcal/d

Secondary Outcome Measures

1. Carbon dioxide elimination [60 minutes]

   Carbon dioxide elimination in ml/min

2. respiratory quotient [60 minutes]

   respiratory Quotient, defined as the Ratio of Carbon dioxide elimination to Oxygen consumption

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Leipzig	Leipzig	Saxony	Germany	D-04103

Sponsors and Collaborators

• University of Leipzig

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sirak Petros, MD, Professor, University of Leipzig
• ClinicalTrials.gov Identifier: NCT04599569
• Other Study ID Numbers: IRATIC-2020
• First Posted: Oct 22, 2020
• Last Update Posted: Jun 28, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sirak Petros, MD, Professor, University of Leipzig: indirect calorimetry; energy expenditure; carbon dioxide elimination; renal replacement therapy; respiratory quotient
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

No Results Posted as of Jun 28, 2022