The Role of Transdermal CO2 in MDA Level in Patient Under... | NCT05205304

Studies
The Role of Transdermal CO2 in MDA Level in Patient Underwent Abdominal Aortic Temporary Cross Clamp

NCT05205304

Sponsor

Universitas Airlangga

Status

Unknown status

Last Update Posted

Apr 5, 2022Actual

Enrollment

30Estimated

Phase

Phase 4

Conditions

Placenta Accreta

Interventions

D'Oxyva

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Jan 3, 2022

First Submission Date that Met QC Criteria

Jan 24, 2022

First Posted Date

Jan 25, 2022Actual

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 3, 2022

Last Update Posted Date

Apr 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hari Daswin Pagehgiri, Resident of Thoracic, Cardiac, and Vascular Surgery Department, Universitas AirlanggaPrincipal Investigator

Lead Sponsor

Universitas AirlanggaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Role of Transdermal Carbon Dioxide in Malondialdehyde Level as Predictor of Ischemia Reperfusion Injury in Patients Underwent Abdominal Aortic Temporary Cross Clamp

Detailed Description

Abdominal aortic temporary cross clamping procedures in patients with placenta accreta undergoing hysterectomy have been performed at Dr. Soetomo Hospital Surabaya for a period of 4 years. In the aortic cross-clamping procedure, an ischemic condition occurs, after the cross-clamp is released the distal tissue from the occlusion which was initially in an ischemic state gets blood flow suddenly (reperfusion) causing Ischemia Reperfusion Injury. This study aims to determine the effect of transdermal administration of carbon dioxide (CO2) as a protective factor for ischemia reperfusion injury in patients undergoing Abdominal Aorta Temporary Cross Clamp. The design of this study is experimental in patients who underwent Abdominal Aorta Temporary Cross Clamp. Subjects were divided into two groups. The first group was treated with CO2 transdermal administration and the second group was the control group.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental	Subjects will be treated with liquid carbon dioxide (D'oxyva) administered transdermally on the thumb after the Aortic Cross Clamp is removed	Drug: D'Oxyva
Control group	No Intervention	Subject will not be treated with liquid carbon dioxide (D'oxyva)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
D'Oxyva	Drug	The transdermal CO2 was administered via non-invasive vaporization technique accommodated by deoxyhemoglobin vasodilator (D'Oxyva)	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Malondyaldehyde	The malondyaldehyde concentration of the patient's serum measured by ELISA test method	Basal, 1 hour after aortic cross clamp off

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Placenta Accreta diagnosed with placental accreta index (PAI) based on the results of ultrasound and underwent Abdominal Aorta Clamping Surgery (Control of Bleeding in Accreta)

Exclusion Criteria:

Patients with severe comorbid disorders based on previous clinical examination: chronic kidney disease, heart disease
Patients with septic shock and sepsis
Patients with peripheral artery disease

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hari Daswin Pagehgiri	Recruiting	Surabaya	Bali	80116	Indonesia

Condition Browse Module

MeSH Terms

ID	Term
D010921	Placenta Accreta

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

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