NCT04412980

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
Last Updated

November 24, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

May 18, 2020

Last Update Submit

November 23, 2020

Conditions

Intensive Care Unit Syndrome

Keywords

Continuous renal replacement therapy with regional citrate anticoagulation (CRRT-RCA)Ionized hypomagnesemiaMonitoring of ionized magnesemiaMorbi-moratlity

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 0 and Day 1

Secondary Outcomes (2)

  • Proportion of patients with heart rhythm disturbances

    1 day

  • Assessment of morbidity and mortality

    1 day

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to the ICU and requiring CRRT-RCA

You may qualify if:

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

You may not qualify if:

  • Persons under protection
  • Paritcipation rejections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

NC

Study Officials

  • Romaric Larcher, MD PhD

    UH Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

June 2, 2020

Study Start

May 1, 2020

Primary Completion

October 1, 2020

Study Completion

November 23, 2020

Last Updated

November 24, 2020

Record last verified: 2020-05

Locations

FR(1)