Evidence map›Paper›PMID 26130237›Full record

Trial reportCritical care (London, England)2015

Ubiquinol (reduced Coenzyme Q10) in patients with severe sepsis or septic shock: a randomized, double-blind, placebo-controlled, pilot trial.

Michael W Donnino, Sharri J Mortensen, Lars W Andersen, Maureen Chase, Katherine M Berg, Julia Balkema, Jeejabai Radhakrishnan, Raúl J Gazmuri, Xiaowen Liu, Michael N Cocchi

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01948063 (Ubiquinol), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01948063 phase2completednot on this map

Ubiquinol (Reduced COQ10) for Patients With Sepsis

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2012 to 2014Enrolled38ConditionsSepsisArmsUbiquinol, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Michael W DonninoDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road West CC-2, Boston, MA, 02215, USA. mdonnino@bidmc.harvard.edu.
Sharri J MortensenDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road West CC-2, Boston, MA, 02215, USA. sharri89@hotmail.com.
Lars W AndersenDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road West CC-2, Boston, MA, 02215, USA. lwanders@bidmc.harvard.edu.
Maureen ChaseDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road West CC-2, Boston, MA, 02215, USA. mchase1@bidmc.harvard.edu.
Katherine M BergDepartment of Medicine, Division of Pulmonary and Critical Care, Beth Israel Deaconess Medical Center, One Deaconess Road West CC-2, Boston, MA, USA. kberg@bidmc.harvard.edu.
Julia BalkemaDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road West CC-2, Boston, MA, 02215, USA. jbalkema@bidmc.harvard.edu.
Jeejabai RadhakrishnanResuscitation Institute at Rosalind Franklin University of Medicine and Science, 3333 Green Bay Road, North Chicago, IL, 60064, USA. jeejabai.radhakrishnan@rosalindfranklin.edu.
Raúl J GazmuriResuscitation Institute at Rosalind Franklin University of Medicine and Science, 3333 Green Bay Road, North Chicago, IL, 60064, USA. raul.gazmuri@rosalindfranklin.edu.
Xiaowen LiuDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road West CC-2, Boston, MA, 02215, USA. xliu4@bidmc.harvard.edu.
Michael N CocchiDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, One Deaconess Road West CC-2, Boston, MA, 02215, USA. mcocchi@bidmc.harvard.edu.
Beth Israel Deaconess Medical Center · USRosalind Franklin University of Medicine and Science · US

Funding

Statin Therapy in Acute InfluenzaK23GM101463 · NIGMS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI CHASE, MAUREEN · 2013 to 2017
$798k
Effect of Thiamine on Pyruvate Dehydrogenase Activity in Septic ShockK02HL107447 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI DONNINO, MICHAEL WILLIAM · 2012 to 2014
$309k
NHLBI NIH HHS 1K02HL107447.01A1NHLBI NIH HHS K02 HL107447NIGMS NIH HHS K23 GM101463
6 · The paper itself

Abstract

introductionWe previously found decreased levels of Coenzyme Q10 (CoQ10) in patients with septic shock. The objective of the current study was to assess whether the provision of exogenous ubiquinol (the reduced form of CoQ10) could increase plasma CoQ10 levels and improve mitochondrial function.

methodsWe performed a randomized, double-blind, pilot trial at a single, tertiary care hospital. Adults (age ≥18 years) with severe sepsis or septic shock between November 2012 and January 2014 were included. Patients received 200 mg enteral ubiquinol or placebo twice a day for up to seven days. Blood draws were obtained at baseline (0 h), 12, 24, 48, and 72 h. The primary outcome of the study was change in plasma CoQ10 parameters (total CoQ10 levels, CoQ10 levels relative to cholesterol levels, and levels of oxidized and reduced CoQ10). Secondary outcomes included assessment of: 1) vascular endothelial biomarkers, 2) inflammatory biomarkers, 3) biomarkers related to mitochondrial injury including cytochrome c levels, and 4) clinical outcomes. CoQ10 levels and biomarkers were compared between groups using repeated measures models.

resultsWe enrolled 38 patients: 19 in the CoQ10 group and 19 in the placebo group. The mean patient age was 62 ± 16 years and 47% were female. Baseline characteristics and CoQ10 levels were similar for both groups. There was a significant increase in total CoQ10 levels, CoQ10 levels relative to cholesterol levels, and levels of oxidized and reduced CoQ10 in the ubiquinol group compared to the placebo group. We found no difference between the two groups in any of the secondary outcomes.

conclusionsIn this pilot trial we showed that plasma CoQ10 levels could be increased in patients with severe sepsis or septic shock, with the administration of oral ubiquinol. Further research is needed to address whether ubiquinol administration can result in improved clinical outcomes in this patient population.

trial registrationClinicaltrials.gov identifier NCT01948063. Registered on 18 February 2013.

Indexed as

CholesterolCytochromes cDouble-Blind MethodFemaleHumansInterleukinsMaleMicronutrientsMiddle AgedPilot ProjectsSepsisShock, SepticUbiquinoneVascular Cell Adhesion Molecule-1Vascular Endothelial Growth Factor ACholesterolcoenzyme Q10Cytochromes cInterleukinsMicronutrientsubiquinolUbiquinoneVascular Cell Adhesion Molecule-1Vascular Endothelial Growth Factor A

Identifiers

PMID26130237
PMCPMC4520066
OpenAlexW1727067195

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.