NCT02681653

Brief Summary

Sepsis is a common, expensive, frequently fatal and highly complex inflammatory syndrome wherein multiple cellular and humoral pathways are involved. Since it's a multifactorial syndrome merely blocking one of the various inflammatory pathways may not suffice to provide effective treatment and this may partly explain why most of the adjunctive therapies developed for severe sepsis have yielded disappointing results in rigorous clinical trials. Statins have varied pleiotropic effects on the inflammatory mediators and there addition to the current adjuvant therapies in septic shock may help in reduction of mortality. The present trial aims to study survival benefit and changes in bio-marker levels in septic shock. Adult patients (\>=18 years) in septic shock and admitted to ICU will be included in the study. Patients will be randomized as per computer generated random number into the Drug (Atorvastatin, 40 mg) or matched placebo group. Drug or placebo will be given to selected patient via nasogastric tube for 7 days. Bio markers (Il-6, TNF-alpha) estimated during the trial week (Days 1, 4, and 7). All clinical and study personnel and patients remained blinded to the study group assignment throughout the trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

January 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
Last Updated

February 12, 2016

Status Verified

December 1, 2015

Enrollment Period

2.8 years

First QC Date

September 15, 2015

Last Update Submit

February 11, 2016

Conditions

Septic Shock

Keywords

StatinsSeptic Shock

Outcome Measures

Primary Outcomes (1)

  • Mortality

    28 day mortality after inclusion in study.

    28 day of ICU stay

Secondary Outcomes (6)

  • Cytokines in septic shock

    Day 1, 4 and 7 of commencement of trial drug.

  • Vasopressor free days.

    28 days after commencement of trial drug.

  • Ventilation free days.

    28 days after commencement of trial drug.

  • Renal replacement free days.

    28 days after commencement of trial drug.

  • Transfusion free days.

    28 days after commencement of trial drug.

  • +1 more secondary outcomes

Study Arms (2)

Statin

ACTIVE COMPARATOR

Atorvastatin, 40 mg for 7 days in patients of septic shock admitted to ICU

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Matched placebo, 40 mg for 7 days in patients of septic shock admitted to ICU

Drug: Placebo

Interventions

AtorvastatinDRUG

Atorvastatin or placebo given for 7 days to patients of septic shock admitted to ICU

Statin
PlaceboDRUG

Equally matched placebo for 7 days to patients of septic shock admitted to ICU

Placebo

Eligibility Criteria

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

You may qualify if:

  • Clinical disease of septic shock
  • Aged eighteen years and above
  • Admitted to ICU

You may not qualify if:

  • Previous statin induced myopathy or hypersensitivity reaction
  • Greater than two and half times elevated liver transaminases
  • Chronic liver disease
  • Pregnant or lactating mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Critical Care Medicine

Lucknow, Uttar Pradesh, 226014, India

Location

Department of Immunology, SGPGIMS

Lucknow, Uttar Pradesh, 226014, India

Location

Related Publications (1)

  • Singh RK, Agarwal V, Baronia AK, Kumar S, Poddar B, Azim A. The Effects of Atorvastatin on Inflammatory Responses and Mortality in Septic Shock: A Single-center, Randomized Controlled Trial. Indian J Crit Care Med. 2017 Oct;21(10):646-654. doi: 10.4103/ijccm.IJCCM_474_16.

    PMID: 29142375DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Ratender K Singh, MD.

    Sanjay Gandhi Post Graduate Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2015

First Posted

February 12, 2016

Study Start

January 1, 2012

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

February 12, 2016

Record last verified: 2015-12

Locations

IN(2)