Plasma CO2 Removal Due to CRRT and Its Influence on Indirect Calorimetry (MECCIAS)

May 17, 2022 updated by: Elisabeth De Waele, Universitair Ziekenhuis Brussel

MEtabolic Consequences of Continuous Renal Replacement Therapy and Impact on Indirect cAlorimetry Study

The aim of the present study is to assess the metabolic impact of Continuous Renal Replacement Therapy and overview the obstacles and important factors compromising the use of Indirect Calorimetry in CRRT and suggest a model to overcome these issues.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute kidney injury (AKI) complicates a critical illness from 13% up to 78%, needing renal replacement therapy (RRT) up to10 % of all patients in the intensive care unit (ICU). Both intermittent (IRRT) and continuous renal replacement therapy (CRRT) are used. The advantage of the latter is that it has lesser influence on hemodynamics and is better tolerated in critical ill patients.

Another complication during their stay is the inability to feed themselves. Nutrition is a cornerstone in the care for the critical ill and should be started within 3 days of admission to the intensive care unit. To optimize a nutritional prescription, protein and energy targets need to be defined. Predicting formulae based on anthropometric measures and other parameters can be used to calculate the caloric need but indirect calorimetry (IC) remains the gold standard. Caloric need can be derived from Energy expenditure which is calculated with the Weir's equation using carbon dioxide (CO2) production (VCO2) and oxygen (O2) consumption (VO2). Therefore, it is underestimated if CO2 is lost through other means than the normal respiratory route. Hence one of the contra-indications of IC is CRRT.

The totalCO2 (tCO2) travels through the vascular structures within the red blood cells or inside plasma. There, most of the content has 3 different forms: as physically dissolved CO2, bicarbonate, and carbamino compounds. These compounds are in equilibrium with each other. During RRT, a potential loss of CO2 and its different forms may occur due to ultrafiltration in the dialysate. No large trials were conducted trying to quantify this loss nor identifying the determining factors which can be used to predict this loss. Indeed, one author even found a gain in tCO2 of the blood during dialysis with acetate. Trisodiumcitrate is used as an anticoagulant during CRRT. It is a weak base and due to pH change may alter the equilibrium of the Henderson-Hasselbalch equation and thus influence the balance between CO2 and HCO3- and its extraction through CRRT.

Although indirect calorimetry in the intensive care unit has been evaluated during CRRT, the loss of tCO2was not considered. The investigators explored the possibility to predict and easily calculate this CO2 exchange so IC can be used during CRRT.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AKI requiring CRRT
  • Patient on CRRT who's filter you want to change

  • Expected stable patient during the test ( +- 2h) evaluated at discretion of physician :

    • No alteration in medication
    • Stable respiratory settings where no change in conditions is expected. If possible, controlled mode ventilation is preferred.
    • Expected stable pH and lactate
    • no intervention will be made on patient (transport/washing/physiotherapy/…)
    • no alterations on settings of CRRT is expected to be made.
  • Maximal respiratory settings: max FiO2: 60% / max inspiratory plateau pressure 30 mmHg/max tidal volumes 8ml/kg
  • pH between 7,30-7,50, lactate levels <2,0

  • starting settings CRRT with citrate:

    • Blood pump flow: 150 ml/min
    • Predilution ( citrate): 1500-2300ml/h
    • Dialysate dose: 25-40 ml/kg/h
    • ultrafiltration: 0-300 ml /h
    • Substitution: NaCl 300-800 ml/h or B22: 400-2000 ml/h

Exclusion Criteria:

  • Pregnancy / lactation
  • Contra-indications for the use of indirect calorimetry as stated by the AARC (FiO2>60%, chest tubes)
  • Severe hemodynamic or ventilator instability.
  • CRRT modalities unusual to daily clinical ICU practice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: all patients
Classic CRRT with citrate predilution
Diagnostic test: blood gas analysis under citrate predilution
blood gas analysis of blood on different sample points and dialysis fluid
Device: filter replacement
Using local protocol: stop and disconnect CRRT, replace filter and reconnect and restart CRRT.
Device: IC
monitor patients during the whole study period with indirect calorimetry
Drug: NaCl predilution
Replace citrate predilution with NaCl
Diagnostic test: blood gas analysis under NaCl predilution
repeat blood gas analysis of blood on different sample points and dialysis fluid
Drug: double ultrafiltration
double the ultrafiltration fluid by augmenting post dilution fluid and keeping ultrafiltration at the same rate.
Diagnostic test: blood gas analysis under citrate predilution and double ultrafiltration rate
repeat blood gas analysis of blood on different sample points and dialysis fluid
Dietary supplement: pause and restart nutritional therapy
pause parenteral and enteral nutrition before indirect calorimetry is performed. and restart after first blood analysis for vitamine status
Diagnostic test: evolution of vitamin and trace elements
blood analysis for vitamin and trace elements. Perform this blood analysis after restart of CRRT but before restart of nutritional therapy, 30 minutes after restart of nutritional therapy and 24h after restart of nutritional therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in CO2 flow and O2 flow on different sample points of CRRT
Time Frame: 2hours

CO2 flow and O2 flow ( ml/min) will be compared between the different sample points on CRRT with and without citrate.

CO2 flow and O2 flow is calculated by multiplying fluid flow ( ml/min) on different sample points of CRRT with CO2 content or O2 content of fluid on respective sample points during CRRT with and without Citrate.
2hours
REE change due to CRRT
Time Frame: 2hours

REE ( Kcal) will be measured during the whole procedure using IC. REE will be measured during CRRT. citrate wil be replaced by NaCl 0,9% fluid and REE will be measured. After this, CRRT will be stopped and REE will be measured. The difference in REE during CRRT with and without citrate and without CRRT will be calculated and compared.

REE is calculated using the weir equation and VO2, VCO2. VO2 and VCO2 is calculated using FiO2, FeO2, FiCO2, FeCO2 and VE.
2hours
does change in CO2 flow and O2 flow on different sample points of CRRT correlate with VCO2 and VO2 change due to CRRT with or without citrate
Time Frame: 2 hours
VCO2 and VO2 change due to CRRT and due to citrate will be correlated with change in CO2 and O2 flow of fluids passing through CRRT with or without citrate.
2 hours
Are vitamins and trace elements sufficiently supplemented with standard nutritional therapy during CRRT
Time Frame: 24hours
blood analysis for concentrations of Vitamin A, B1, B6, B9, B12, C, D, E ; trace elements selenium, zinc, copper, chrome; and cholesterol and triglyceride
24hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VCO2 and VO2 change due to CRRT with or without citrate
Time Frame: 2 hours
VCO2 and VO2 ( ml/min) will be measured during the whole procedure using IC. VCO2 and VO2 will be measured during CRRT with citrate. citrate wil be replaced by NaCl 0,9% fluid and VCO2 and VO2 will be measured. After this, CRRT will be stopped and VCO2 and VO2 will be measured. The difference in VCO2 and VO2 during CRRT with or without citrate and without CRRT will be calculated and compared. VO2 and VCO2 is calculated using FiO2, FeO2, FiCO2, FeCO2 and VE.
2 hours
FiO2, FeO2, FiCO2 and FeCO2 change due to CRRT with or without citrate
Time Frame: 2hours
FiO2, FeO2, FiCO2 and FeCO2 ( %) will be measured during the whole procedure using IC. FiO2, FeO2, FiCO2 and FeCO2 will be measured during CRRT with citrate. citrate wil be replace by NaCl0,9% fluid and FiO2, FeO2, FiCO2 and FeCO2 will be measured. After this CRRT will be stopped and FiO2, FeO2, FiCO2 and FeCO2 will be measured. The difference in FiO2, FeO2, FiCO2 and FeCO2 during CRRT with or without citrate and without CRRT will be calculated.
2hours
VE change due to CRRT with or without citrate
Time Frame: 2hours
VE( ml/min) will be measured during the whole procedure using IC. VE will be measured during CRRT with citrate. citrate wil be replace by NaCl0,9% fluid and VE will be measured. After this CRRT will be stopped and VE will be measured. The difference in VE during CRRT with or without citrate and without CRRT will be calculated.
2hours
change in CO2 and O2 content of fluid passing through CRRT
Time Frame: 2hours
using blood gas analyser, CO2 content and O2content ( mmol/L)of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared.
2hours
change in bicarbonate content of fluid passing through CRRT
Time Frame: 2hours
using blood gas analyser, bicarbonate ( mmol/L) of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared.
2hours
change in pH change of fluid passing through CRRT
Time Frame: 2hours
using blood gas analyser, pH of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared
2hours
change in pCO2 and pO2 change of fluid passing through CRRT
Time Frame: 2hours
using blood gas analyser, pCO2 and pO2 (mmHg) of fluid on different sample points in extracorporeal circuit of CRRT with or without citrate will be analysed and compared.
2hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2017

Primary Completion (Actual)

March 15, 2019

Study Completion (Actual)

March 15, 2019

Study Registration Dates

First Submitted

July 3, 2017

First Submitted That Met QC Criteria

October 14, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.U.N. 143201731636

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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