The Prognostic Value of Anion Gap in Predicting Mortality... | NCT06583616

Studies
The Prognostic Value of Anion Gap in Predicting Mortality Among Patients With Acute Pulmonary Embolism

NCT06583616

Sponsor

Universitas Diponegoro

Status

Recruiting

Last Update Posted

Sep 4, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Acute Pulmonary Embolism (PE)

Interventions

Anion Gap

Countries

Indonesia

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

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Aug 31, 2024Actual

Completion Date

Sep 30, 2024Estimated

First Submitted Date

Aug 30, 2024

First Submission Date that Met QC Criteria

Sep 2, 2024

First Posted Date

Sep 4, 2024Actual

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

Sep 2, 2024

Last Update Posted Date

Sep 4, 2024Actual

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

This study aims to evaluate the prognostic value of the anion gap in predicting mortality among patients with acute pulmonary embolism.

Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as acute pulmonary embolism by using computed tomography scan (CT scan). The data consist of demographic data, clinical presentation, laboratory, and CT scan were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.

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

Yes

Target Follow-Up Duration

7 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Survival Group		Patient with acute pulmonary embolism who survive after hospitalization	Diagnostic Test: Anion Gap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anion Gap	Diagnostic Test	Patient with acute pulmonary embolism who not survive after hospitalization	Survival Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-hospital mortality		During hospitalization, up to 1 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age: 18 - 70 years old
patient with acute pulmonary embolism

Exclusion Criteria -- patient with history of:

heart failure
valvular heart disease
chronic obstructive pulmonary disease
congenital heart disease
sepsis
chronic kidney disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patient with acute pulmonary embolism

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leo Deddy Pradipta, MD	Contact	+6281316499074		dancingdeagle@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Kariadi Central General Hospital	Recruiting	Semarang	Central of Java		Indonesia

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

Intervention Browse Module

MeSH Terms

ID	Term
D000136	Acid-Base Equilibrium

Ancestor Terms

ID	Term
D001669	Biochemical Phenomena
D055598	Chemical Phenomena
D006863	Hydrogen-Ion Concentration
D008660	Metabolism

Browse Leaves

Not provided

Browse Branches

Not provided