Red Cell Distribution Width as a Predictor of Mortality i... | NCT04064801

Studies
Red Cell Distribution Width as a Predictor of Mortality in Acute Methanol Poisoning

NCT04064801

Sponsor

Adana Numune Training and Research Hospital

Status

Completed

Last Update Posted

Apr 15, 2021Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Methanol Poisoning

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Apr 2021

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

Mar 15, 2020Actual

Primary Completion Date

May 30, 2020Actual

Completion Date

Aug 30, 2020Actual

First Submitted Date

Aug 20, 2019

First Submission Date that Met QC Criteria

Aug 20, 2019

First Posted Date

Aug 22, 2019Actual

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

Apr 12, 2021

Last Update Posted Date

Apr 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Barış Arslan, Adana City Training and Research Hospital, Adana Numune Training and Research HospitalPrincipal Investigator

Lead Sponsor

Adana Numune Training and Research HospitalOTHER_GOV

Collaborators

Not provided

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

The study aimed to investigate the association between RDW and in-hospital mortality in methanol poisoning.

Detailed Description

RDW values have been found to be an independent predictor of the prognosis among patients with heart diseases, stroke,community-acquired pneumonia (CAP), pulmonary embolism, chronic obstructive pulmonary disease (COPD), septic shock, and acute pancreatitis.

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

No data available

No data is available for this block.

Enrollment

42Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital mortality		7 day
Need for mechanical ventilation		7 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients aged ≥18 years who were admitted to emergency departments from January 2019 to January 2020 on account of acute methanol intoxication.

Exclusion Criteria:

Incomplete data, Malignancy, Severe anaemia, History of erythrocyte transfusion last 6 weeks

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with acute methanol toxicity who were diagnosed and treated at the Adana City Training and Research Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Adana City Training and Research Hospital		Adana		01170	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided