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Continuous Renal Replacement TherapyMECCIASNCT03314363

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

A study testing blood gas analysis under citrate predilution, filter replacement and IC in people with Continuous Renal Replacement Therapy and CO2 Removal, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
blood gas analysis under citrate predilution, filter replacement and IC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteBelgium
Study dates
26 Apr 2017to 15 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • universitair ziekenhuis Brussel

    Brussels, 1090

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
blood gas analysis under citrate predilution, filter replacement, IC, NaCl predilution, blood gas analysis under NaCl predilution
Keywords
Calorimetry, Indirect, respiratory dialysis
Medical subject headings
Malnutrition, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood gas analysis under citrate predilutionDiagnostic test

    blood gas analysis of blood on different sample points and dialysis fluid

  • filter replacementDevice

    Using local protocol: stop and disconnect CRRT, replace filter and reconnect and restart CRRT.

  • ICDevice

    monitor patients during the whole study period with indirect calorimetry

  • NaCl predilutionDrug

    Replace citrate predilution with NaCl

  • blood gas analysis under NaCl predilutionDiagnostic test

    repeat blood gas analysis of blood on different sample points and dialysis fluid

  • double ultrafiltrationDrug

    double the ultrafiltration fluid by augmenting post dilution fluid and keeping ultrafiltration at the same rate.

  • blood gas analysis under citrate predilution and double ultrafiltration rateDiagnostic test

    repeat blood gas analysis of blood on different sample points and dialysis fluid

  • pause and restart nutritional therapyDietary supplement

    pause parenteral and enteral nutrition before indirect calorimetry is performed. and restart after first blood analysis for vitamine status

  • evolution of vitamin and trace elementsDiagnostic test

    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.

Study groups in NCT03314363
Study groupRoleWhat they receive
all patientsOtherClassic CRRT with citrate predilution
Receives: Diagnostic Test: blood gas analysis under citrate predilution; Device: filter replacement; Device: IC; Drug: NaCl predilution; Diagnostic Test: blood gas analysis under NaCl predilution; Drug: double ultrafiltration; Diagnostic Test: blood gas analysis under citrate predilution and double ultrafiltration rate; Dietary Supplement: pause and restart nutritional therapy; Diagnostic Test: evolution of vitamin and trace elements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in CO2 flow and O2 flow on different sample points of CRRT

    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.

    Measured: 2hours

  2. REE change due to CRRT

    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.

    Measured: 2hours

  3. 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

    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.

    Measured: 2 hours

  4. Are vitamins and trace elements sufficiently supplemented with standard nutritional therapy during CRRT

    blood analysis for concentrations of Vitamin A, B1, B6, B9, B12, C, D, E ; trace elements selenium, zinc, copper, chrome; and cholesterol and triglyceride

    Measured: 24hours

Secondary outcomes (7)

  1. VCO2 and VO2 change due to CRRT with or without citrate

    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.

    Measured: 2 hours

  2. FiO2, FeO2, FiCO2 and FeCO2 change due to CRRT with or without citrate

    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.

    Measured: 2hours

  3. VE change due to CRRT with or without citrate

    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.

    Measured: 2hours

  4. change in CO2 and O2 content of fluid passing through CRRT

    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.

    Measured: 2hours

  5. change in bicarbonate content of fluid passing through CRRT

    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.

    Measured: 2hours

  6. change in pH change of fluid passing through CRRT

    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

    Measured: 2hours

  7. change in pCO2 and pO2 change of fluid passing through CRRT

    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.

    Measured: 2hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2017
  2. Study start26 Apr 2017
  3. Primary completion15 Mar 2019
  4. Study completion15 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03314363
Sponsor's protocol ID
B.U.N. 143201731636
Acronym
MECCIAS
Status last verified
May 2022
First submitted
3 Jul 2017
Last updated
18 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Case J, Khan S, Khalid R, Khan A. Epidemiology of acute kidney injury in the intensive care unit. Crit Care Res Pract. 2013;2013:479730. doi: 10.1155/2013/479730. Epub 2013 Mar 21.

    PubMed 23573420

  • Metnitz PG, Krenn CG, Steltzer H, Lang T, Ploder J, Lenz K, Le Gall JR, Druml W. Effect of acute renal failure requiring renal replacement therapy on outcome in critically ill patients. Crit Care Med. 2002 Sep;30(9):2051-8. doi: 10.1097/00003246-200209000-00016.

    PubMed 12352040

  • Rabindranath K, Adams J, Macleod AM, Muirhead N. Intermittent versus continuous renal replacement therapy for acute renal failure in adults. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD003773. doi: 10.1002/14651858.CD003773.pub3.

    PubMed 17636735

  • Singer P, Berger MM, Van den Berghe G, Biolo G, Calder P, Forbes A, Griffiths R, Kreyman G, Leverve X, Pichard C, ESPEN. ESPEN Guidelines on Parenteral Nutrition: intensive care. Clin Nutr. 2009 Aug;28(4):387-400. doi: 10.1016/j.clnu.2009.04.024. Epub 2009 Jun 7.

    PubMed 19505748

  • Wichansawakun S, Meddings L, Alberda C, Robbins S, Gramlich L. Energy requirements and the use of predictive equations versus indirect calorimetry in critically ill patients. Appl Physiol Nutr Metab. 2015 Feb;40(2):207-10. doi: 10.1139/apnm-2014-0276. Epub 2014 Oct 27.

    PubMed 25610953

  • Oshima T, Berger MM, De Waele E, Guttormsen AB, Heidegger CP, Hiesmayr M, Singer P, Wernerman J, Pichard C. Indirect calorimetry in nutritional therapy. A position paper by the ICALIC study group. Clin Nutr. 2017 Jun;36(3):651-662. doi: 10.1016/j.clnu.2016.06.010. Epub 2016 Jun 22.

    PubMed 27373497

  • Honore PM, De Waele E, Jacobs R, Mattens S, Rose T, Joannes-Boyau O, De Regt J, Verfaillie L, Van Gorp V, Boer W, Collin V, Spapen HD. Nutritional and metabolic alterations during continuous renal replacement therapy. Blood Purif. 2013;35(4):279-84. doi: 10.1159/000350610. Epub 2013 May 8.

    PubMed 23689499

  • AARC clinical practice guideline. Metabolic measurement using indirect calorimetry during mechanical ventilation. American Association for Respiratory Care. Respir Care. 1994 Dec;39(12):1170-5. No abstract available.

    PubMed 10146137

  • Bosch JP, Glabman S, Moutoussis G, Belledonne M, von Albertini B, Kahn T. Carbon dioxide removal in acetate hemodialysis: effects on acid base balance. Kidney Int. 1984 May;25(5):830-7. doi: 10.1038/ki.1984.97.

    PubMed 6433099

  • Scheinkestel CD, Kar L, Marshall K, Bailey M, Davies A, Nyulasi I, Tuxen DV. Prospective randomized trial to assess caloric and protein needs of critically Ill, anuric, ventilated patients requiring continuous renal replacement therapy. Nutrition. 2003 Nov-Dec;19(11-12):909-16. doi: 10.1016/s0899-9007(03)00175-8.

    PubMed 14624937

  • Wu C, Wang X, Yu W, Li P, Liu S, Li J, Li N. Short-term consequences of continuous renal replacement therapy on body composition and metabolic status in sepsis. Asia Pac J Clin Nutr. 2016;25(2):300-7. doi: 10.6133/apjcn.2016.25.2.29.

    PubMed 27222413

  • Jonckheer J, Spapen H, Debain A, Demol J, Diltoer M, Costa O, Lanckmans K, Oshima T, Honore PM, Malbrain M, De Waele E. CO2 and O2 removal during continuous veno-venous hemofiltration: a pilot study. BMC Nephrol. 2019 Jun 17;20(1):222. doi: 10.1186/s12882-019-1378-y.

    PubMed 31208356

Questions about this trial

What is this clinical trial studying?

A study testing blood gas analysis under citrate predilution, filter replacement and IC in people with Continuous Renal Replacement Therapy and CO2 Removal, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in CO2 flow and O2 flow on different sample points of CRRT (time frame: 2hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03314363, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.

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