NCT01948063

Brief Summary

This study aims to determine if Ubiquinol (reduced form of COQ10) will attenuate mitochondrial injury and decrease inflammatory response in patients suffering from sepsis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_2 sepsis

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 24, 2017

Completed
Last Updated

April 24, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

February 18, 2013

Results QC Date

March 1, 2016

Last Update Submit

March 11, 2017

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • CoQ10 Levels

    Total CoQ10 levels (mcg/mL) at 24 hours post study drug admission.

    24 hours after study drug administration

Study Arms (2)

Control

PLACEBO COMPARATOR

Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.

Dietary Supplement: Placebo

Ubiquinol

EXPERIMENTAL

Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.

Drug: Ubiquinol

Interventions

UbiquinolDRUG

Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.

Ubiquinol
PlaceboDIETARY_SUPPLEMENT

Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.

Also known as: placebo pill or a liquid placebo (Ensure)
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old
  • Suspected or confirmed infection
  • Presence of 2 or more systemic inflammatory response syndrome (SIRS) criteria
  • Admission to the ICU

You may not qualify if:

  • Under 18 years old
  • Current CoQ10 supplementation
  • Unable to receive enteral medications
  • Would need a nasogastric or orogastric tube solely for the purposes of the study
  • Pregnancy, incarceration, mentally disability
  • Patient confirmed Comfort measures only, Do not resuscitate (DNR) and/or Do not intubate. Patients with DNR but intubated and being provided full care are eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Donnino MW, Mortensen SJ, Andersen LW, Chase M, Berg KM, Balkema J, Radhakrishnan J, Gazmuri RJ, Liu X, Cocchi MN. Ubiquinol (reduced Coenzyme Q10) in patients with severe sepsis or septic shock: a randomized, double-blind, placebo-controlled, pilot trial. Crit Care. 2015 Jul 1;19(1):275. doi: 10.1186/s13054-015-0989-3.

    PMID: 26130237DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

ubiquinol

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Michael W Donnino
Organization
BIDMC
mdonnino@bidmc.harvard.edu
617-754-2341

Study Officials

  • Michael Donnino, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

February 18, 2013

First Posted

September 23, 2013

Study Start

October 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 24, 2017

Results First Posted

April 24, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)