Intensive Care Unit SyndromeMagiCCNCT04412980
Ionized Magnesium for Monitoring of Citrate-anticoagulated CVVHD
An observational study of Intensive Care Unit Syndrome, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intensive Care Unit Syndrome
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 23 Nov 2020
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the ICU and requiring CRRT-RCA
Who may be able to join
- Consecutive patients admitted to the ICU and requiring continuous renal replacement therapy with regional citrate anticoagulation
- age > 18 ans
Who cannot join
- Persons under protection
- Paritcipation rejections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- Continuous renal replacement therapy with regional citrate anticoagulation (CRRT-RCA), Ionized hypomagnesemia, Monitoring of ionized magnesemia, Morbi-moratlity
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the systemic ionized magnesemia change after 24h of CRRTsystemic variations of iMg
assess the systemic ionized magnesemia change after 24h of CRRT wiith regional citrate anticoagulation
Measured: Day 0 and Day 1
Secondary outcomes (2)
Proportion of patients with heart rhythm disturbances
Proportion of patients with heart rhythm disturbances
Measured: 1 day
Assessment of morbidity and mortality
Assessment of morbidity and mortality
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 May 2020
- Primary completion1 Oct 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Novamedica Laboratories
- Responsible party
- Sponsor
- Investigators
- Romaric Larcher, MD PhD, Study director, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412980
- Sponsor's protocol ID
- RECHMPL20_0121
- Acronym
- MagiCC
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Ionized Magnesium Measurement for Monitoring of Continuous Venovenous Haemodialysis With Citrate Anticoagulation
- ClinicalTrials.gov ID
- NCT04412980
- Acronym / sponsor ID
- MagiCC / RECHMPL20_0121
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- Continuous renal replacement therapy with regional citrate anticoagulation (CRRT-RCA), Ionized hypomagnesemia, Monitoring of ionized magnesemia, Morbi-moratlity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Novamedica Laboratories
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the ICU and requiring CRRT-RCA
Key inclusion criteria (2 listed)
- Consecutive patients admitted to the ICU and requiring continuous renal replacement therapy with regional citrate anticoagulation
- age > 18 ans
Key exclusion criteria (2 listed)
- Persons under protection
- Paritcipation rejections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Proportion of patients with heart rhythm disturbances
Time frame: 1 day
Assessment of morbidity and mortality
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: Undecided. NC
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Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romaric Larcher, MD PhD study director
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Syndrome, run by University Hospital, Montpellier at 1 site in France.
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 2 inclusion and 2 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 24 Nov 2020. 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 France. 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?
assess the systemic ionized magnesemia change after 24h of CRRTsystemic variations of iMg (time frame: Day 0 and Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2020.