Ionized Magnesium for Monitoring of Citrate-anticoagulated CVVHD (MagiCC)

November 23, 2020 updated by: University Hospital, Montpellier

Importance of Ionized Magnesium Measurement for Monitoring of Continuous Venovenous Haemodialysis With Citrate Anticoagulation

It has been reported in several studies that ionized hypomagnesemia is associated with higher morbidity and mortality rates. During continuous renal replacement therapy with regional citrate anticoagulation (CRRT-RCA), the loss of magnesium has been reported to not be covered by magnesium concentration in ordinary dialysis fluid. This may lead to ionized hypomagnesemia. However the incidence of ionized hypomagnesemia in patients requiring CRRT-RCA remains unclear and need to be estimated to determine if ionized magnesium monitoring could be of interest. This study aim to assess the incidence of ionized hypomagnesemia induced by CRRT-RCA.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

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

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

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

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to the ICU and requiring CRRT-RCA

Description

Inclusion criteria:

  • Consecutive patients admitted to the ICU and requiring continuous renal replacement therapy with regional citrate anticoagulation
  • age > 18 ans

Exclusion criteria:

  • Persons under protection
  • Paritcipation rejections

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess the systemic ionized magnesemia change after 24h of CRRTsystemic variations of iMg
Time Frame: Day 0 and Day 1
assess the systemic ionized magnesemia change after 24h of CRRT wiith regional citrate anticoagulation
Day 0 and Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with heart rhythm disturbances
Time Frame: 1 day
Proportion of patients with heart rhythm disturbances
1 day
Assessment of morbidity and mortality
Time Frame: 1 day
Assessment of morbidity and mortality
1 day

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Collaborators

Novamedica Laboratories

Investigators

  • Study Director: Romaric Larcher, MD PhD, UH Montpellier

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)

May 1, 2020

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

November 23, 2020

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL20_0121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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