Outcomes of Septic Shock Patients Treated With a Metabolic Resuscitation Bundle Consisting of Intravenous Hydrocortisone, Ascorbic Acid and Thiamine.

NCT03913468 | Completed FDA Drug

• 3 other identifiers: 2018-1310A534285SMPH/MEDICINE/PULMON MED
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective chart review that will measure the impact on outcomes in septic shock patients who were resuscitated with a novel combination of medicines called iHAT (intravenous hydrocortisone -ascorbic acid-thiamine). Septic shock patients treated with this combination of drugs over the past two years will be compared with similar, concurrent septic shock patients who were not treated with this drug given that adoption of this therapy has been variable.

Conditions

Septic Shock; Ascorbic Acid Deficiency

Keywords

ascorbic acid; septic shock; severe sepsis

Outcome Measures

Primary Outcomes (1)

• Duration of Vasopressors

  Length of time requiring IV vasopressors

  At study conclusion, up to 3 months

Secondary Outcomes (2)

• ICU mortality

  At study conclusion, up to 3 months

• Need for Renal Replacement Therapy

  At study conclusion, up to 3 months

Study Arms (2)

Received Ascorbic Acid IV

Per the medical record, consecutive patients admitted to our institutions ICU with a diagnosis of septic shock within the last 3 years, who were treated within the first 24 hours of admission with the combination of IV ascorbic acid, IV thiamine, and IV hydrocortisone, with a duration of 4 days or until patient leaves the ICU.

Drug: Intravenous Ascorbic Acid

Control Group

Per the medical record, consecutive patients admitted to our institutions ICU with a diagnosis of septic shock within the last 3 years, who did not receive any treatment with IV ascorbic acid.

Interventions

Intravenous Ascorbic Acid DRUG

1.5 grams IV ascorbic acid q6h, 50 mg IV hydrocortisone q 6 hours, and 200mg IV thiamine BID administered (as documented in medical record)

Also known as: Metabolic Resuscitation, HAT therapy

Received Ascorbic Acid IV

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU to the medical critical care service with a diagnosis of septic shock

You may qualify if:

• Admitting Provider in the ICU Patient database must be on the Critical Care Service
• Primary diagnosis of sepsis listed in the ICU Patient Database
• Requirement for vasopressors within 24 hours of admission
• If outside transfer, transfer to TLC occurred within 24 hours of initial presentation
• Patient remained on Critical Care service for a minimum of 48 hours
• If treated with iHAT, iHAT started within 36 hours of admission
• No transition to comfort care occurred within the first 24 hours

You may not qualify if:

• patients requiring surgical intervention for source control
• patients transitioned to comfort measures only within 24 hours of admission

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Shock, Septic; Ascorbic Acid Deficiency; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Pierre Kory, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: April 12, 2019
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)