Bionenergetic Balance During CVVH

NCT06483542 | Active Not Recruiting DMC

• 1 other identifier: BUN 1432022000231
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The bioenergetic balance is the sum of energy exchanged during CRRT and is mostly defined by citrate glucose and lactate. When CRRT was performed with the older dialysis fluids, glucose and lactate could be an important source of energy next to citrate when used as predilution (6, 7). During continuous venovenous hemofiltration (CVVH), a subgroup of CRRT which is performed with the newer dialysis fluids without lactate or glucose as advocated by the KDIGOguidelines, glucose and in a minor way lactate mostly induce a loss of energy. The first aim is to determine how this bioenergetic balance impacts energy need compared to the measured energy with indirect calorimetry and how nutrition therapy needs to be adapted. Also, disease specific predicting equation have been created for patients suffering from acute kidney injury treated with renal replacement therapy. How this predicting equation and other existing predicting equations agree with the measured REE has not been validated yet. The second aim is to determine how predictive equations correlate with measured REE in patients treated with CVVH.

Conditions

Acute Kidney Injury; Continuous Venovenous Hemofiltration; Energy Metabolism; Resting Energy Expenditure; Nutrition Therapy

Outcome Measures

Primary Outcomes (1)

• Energy

  expressed in Kcal

  during study completion, on average 4weeks

Secondary Outcomes (2)

• resting energy expenditure

  during study completion, on average 4weeks

• protein to energy ratio

  during study completion, on average 4weeks

Study Arms (1)

Group 1

all patients

Other: bioenergetic balance

Interventions

bioenergetic balance OTHER

Bioenergetic balance is calculated for all patients who had a resting energy expenditure measurement with indirect calorimetry.

Group 1

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult critically ill patients with acute kidney injury who require CVVH

You may qualify if:

• Patients admitted to the adult ICU (01/01/2021-30/09/2022)
• At least one indirect calorimetry measurement (ventilator) or calculation based on harris benedict OR 25Kcal/kg/day
• Combined with bio energetic balance measurement
• Receiving CVVH during intensive care stay

You may not qualify if:

• The absence of an indirect calorimetry measurement (ventilator) or calculation - based on the Harris Benedict OR 25Kcal/kg/day formula OR The absence of a bio energetic balance measurement
• The absence of CVVH during intensive care stay
• Pediatric (intensive care unit) patients

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair ziekenhuis Brussel

Jette, Vlaams Brabant, 1090, Belgium

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Joop Jonckheer, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: July 3, 2024
• Study Start: February 1, 2023
• Primary Completion: April 30, 2023
• Study Completion: September 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: From March 2023 until March 2053

Locations

BE (1)