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Septic ShockNCT03913468

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

An observational study of Septic Shock and Ascorbic Acid Deficiency, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Septic Shock, Ascorbic Acid Deficiency
What is being tested?
Intravenous Ascorbic Acid
Type of treatment
Injection or infusion
How many people
206 participants
Where
1 siteUnited States
Study dates
1 Jan 2019to 1 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53705

Other trials in United States

About this study

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.

Read the detailed description

The condition of septic shock and multi-organ failure directly results from the rapid consumption of ascorbic acid stores in humans suffering an infection (research in septic patients have demonstrated near uniform deficiency/depletion of ascorbic acid on presentation to ICU's).

This rapidly acquired ascorbic acid deficiency leads to shock and multi-organ failure due to the fact that ascorbic acid is required for humans to produce endogenous vasopressors (hormones that regulate blood pressure) as well as to maintain the function and integrity of the endothelium-the endothelium is the largest organ in the body and is critical in regulating blood pressure and preventing fluid leakage into all organs of the body, a pervasive dysfunction which underlies "multi-organ failure". Oral administration of ascorbic acid, even in high doses, has limited bioavailability (transporter mechanisms in the intestines are limited) and does not lead to appreciable correction of the deficiency, neither in the short term, nor in the critically ill.

In contrast, intravenous administration, in high doses, rapidly achieves not only normal levels, but even supranormal levels.This critical need for intravenous supplementation to treat septic shock was first argued for in 2006 by the European Respiratory Society's "Consensus Committee on Intravenous (Parenteral) Vitamin C" a committee comprised of scientists, researchers, and clinicians studying the role ascorbic acid in sepsis/shock models from all over the world. This was followed by two randomized controlled trials in 2014 showing high efficacy of intravenous ascorbic acid in preventing death in septic shock patients. In 2016, a highly publicized historical control trial further demonstrated a large reduction in vasopressor duration, mortality and renal replacement therapy in a cohort of patients after aggressively correcting ascorbic acid deficiency via the intravenous route showing that multi organ failure and death is immediately prevented in almost all patients. More recently, he has published a study demonstrating the synergistic effects of pairing ascorbic acid with hydrocortisone--endothelial barriers are restored to a greater extent than either agent alone.

Lastly, two trials in the past two years have shown that intravenous thiamine, when systematically provided to the critically ill, independently leads to reduced mortality. Thus, HAT therapy appears to be of high utility in preventing death and multi-organ failure in septic shock. Beyond the above mentioned small, single center observational and randomized controlled trials, no other outcome studies have been done in septic shock patients.

Being tested
Intravenous Ascorbic Acid
Keywords
ascorbic acid, septic shock, severe sepsis
Medical subject headings
Shock, Septic, Ascorbic Acid Deficiency, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous Ascorbic AcidDrug

    Also called Metabolic Resuscitation, HAT therapy

    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)

Study groups in NCT03913468
Study groupRoleWhat they receive
Received Ascorbic Acid IVPer 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.
Receives: Drug: Intravenous Ascorbic Acid
Control GroupPer 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Vasopressors

    Length of time requiring IV vasopressors

    Measured: At study conclusion, up to 3 months

Secondary outcomes (2)
  1. ICU mortality

    proportion of patients surviving to ICU discharge

    Measured: At study conclusion, up to 3 months

  2. Need for Renal Replacement Therapy

    Proportion of patients requiring renal replacement therapy

    Measured: At study conclusion, up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2019
  2. Study start1 Jan 2019
  3. Primary completion1 Dec 2019
  4. Study completion1 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03913468
Sponsor's protocol ID
2018-1310
Other IDs
A534285, SMPH/MEDICINE/PULMON MED
Status last verified
Sep 2021
First submitted
6 Feb 2019
Last updated
14 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Septic Shock and Ascorbic Acid Deficiency, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Vasopressors (time frame: At study conclusion, up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.

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