Vitamin C to Reduce Vasopressor Dose in Septic Shock | NCT03835286

Studies
Vitamin C to Reduce Vasopressor Dose in Septic Shock

NCT03835286

Sponsor

Hospital Español de Mexico

Status

Withdrawn

Last Update Posted

Jan 18, 2024Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Septic Shock
Sepsis

Interventions

Vitamin C
Placebos

Countries

Mexico

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 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID 19

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jan 22, 2019

First Submission Date that Met QC Criteria

Feb 7, 2019

First Posted Date

Feb 8, 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

Jan 16, 2024

Last Update Posted Date

Jan 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jose J Zaragoza, MD, Clinical Professor, Hospital Español de MexicoPrincipal Investigator

Lead Sponsor

Hospital Español de MexicoOTHER

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

Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included.

Patients will be randomized to one of the study groups:

Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours.

Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours.

Detailed Description

Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included.

Patients will be randomized to one of the study groups:

Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours.

Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours.

Bottles will be identical, only identified by the sequential number of the patient that has been included.

Primary objective is to demonstrate that the administration of intravenous Vitamin C decreases the dose of exogenous vasopressors in patients with septic shock

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin C	Experimental	Vitamin C experimental group	Drug: Vitamin C
Control	Placebo Comparator	Placebos Controlled group	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin C	Drug	6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.	Vitamin C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vasopressor dose	Hourly dose of exogenous vasopressor	72 hours

Secondary Outcomes

Measure	Description	Time Frame
Hours of vasopressor use	Total hours of vasopressor use	through study completion, an average of 30 days
Days of mechanical ventilation	Total days of mechanical ventilation use

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults
Septic Shock

Exclusion Criteria:

Previous treatment exceeded 24 hours
Refusal to participate
Do Not Resuscitate
Participation in another trial

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ricardo Martinez-Zubieta, MD	Hospital Español de Mexico	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Español		Mexico City		11520	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Complete database will be shared as requested by the publishing journal, once the study is completed

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Available one year after

Access Criteria

Journal provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001205	Ascorbic Acid

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided