Ionized Magnesium for Monitoring of Citrate-anticoagulate... | NCT04412980

Studies
Ionized Magnesium for Monitoring of Citrate-anticoagulated CVVHD

NCT04412980

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Nov 24, 2020Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Intensive Care Unit Syndrome

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Actual

Primary Completion Date

Oct 1, 2020Actual

Completion Date

Nov 23, 2020Actual

First Submitted Date

May 18, 2020

First Submission Date that Met QC Criteria

Jun 1, 2020

First Posted Date

Jun 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2020

Last Update Posted Date

Nov 24, 2020Actual

Name	Class
Novamedica Laboratories	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients admitted to the ICU and requiring CRRT-RCA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Romaric Larcher, MD PhD	UH Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided