NCT04599569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

3.6 years

First QC Date

October 18, 2020

Last Update Submit

December 18, 2024

Conditions

Keywords

indirect calorimetryenergy expenditurecarbon dioxide eliminationrenal replacement therapyrespiratory quotient

Outcome Measures

Primary Outcomes (1)

  • energy expenditure

    energy expenditure in kcal/d

    60 minutes

Secondary Outcomes (2)

  • Carbon dioxide elimination

    60 minutes

  • respiratory quotient

    60 minutes

Interventions

indirect calorimetry with and without renal replacement therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

critically ill mechanically ventilated medical patients requiring renal replacement therapy

You may qualify if:

  • simultaneous requirement for mechanical ventilation and renal replacement therapy
  • informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Leipzig

Leipzig, Saxony, D-04103, Germany

Location

Related Publications (1)

  • Knoll A, Petros S, Pasieka B, Weidhase L. Influence of kidney replacement therapy on indirect calorimetry in critically ill patients. Eur J Clin Nutr. 2025 Nov;79(11):1144-1148. doi: 10.1038/s41430-025-01643-9. Epub 2025 Jul 30.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Calorimetry, Indirect

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CalorimetryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Sirak Petros, MD

    University of Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 18, 2020

First Posted

October 22, 2020

Study Start

October 20, 2020

Primary Completion

May 31, 2024

Study Completion

June 30, 2024

Last Updated

December 20, 2024

Record last verified: 2024-12

Locations