Septic ShockNCT02681653
Study the Impact of Statins in Septic Shock
A study testing Atorvastatin in people with Septic Shock, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 2 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesIndia
- Study dates
- Jan 2012to Jan 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical disease of septic shock
- Aged eighteen years and above
- Admitted to ICU
Who cannot join
- Previous statin induced myopathy or hypersensitivity reaction
- Greater than two and half times elevated liver transaminases
- Chronic liver disease
- Pregnant or lactating mothers
Trial locations and contacts
2 sites in 1 country.
India2 sites
Department of Critical Care Medicine
Lucknow, Uttar Pradesh, 226014
Department of Immunology, SGPGIMS
Lucknow, Uttar Pradesh, 226014
About this study
Official title: Prospective Randomized Study to Assess Impact of Statins in Septic Shock
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.
Read the detailed description
Objectives:
- Study impact of statins on levels of biomarkers (IL-6 and TNF-α) of sepsis.
- Study survival benefit of statins in septic shock.
Introduction:
Sepsis is the leading cause of mortality in non-coronary ICUs. Mortality associated with sepsis is still considerably high. Rising economic burden of managing sepsis is a major concern. Statin is an anti-hyperlipidemic drug with pleiotropic effects. It has properties like anti-inflammatory/oxidative, immunomodulatory effects, enhances endothelial function, reduction in blood thrombogenicity, and increased nitric oxide (NO) bioavailability. Available evidence suggests that statins may play a positive role in reduction of mortality in sepsis. However, the multidimensional heterogeneous character of the available studies does not allow drawing firm conclusions about its usefulness in sepsis and septic shock. This randomized, double blinded, placebo controlled trial is an attempt to study the impact of statins on mortality and biomarker levels in septic shock.
Details of material and methods:
Patients >= age 18 yrs meeting the American European consensus conference definition of septic shock will be enrolled into the study. After the written informed consent from the primary decision maker the patients will be randomized into either the drug or placebo group. Each group will either receive Atorvastatin 40mg or a matched placebo for 7 days. IL-6 and TNF alpha levels will be estimated on D1, D4 and D7 of the trial week. Relevant clinical and laboratory (clinical biochemistry, hematological, coagulation parameters, LFT and renal function tests) will be recorded simultaneously. Severity scores, event free days (vasopressor, ventilation, dialysis, transfusion, parenteral nutrition), and mortality after 28 days of inclusion in study will be recorded.
Ethical Issues:
Written informed consent will be taken from either the patient (if possible) or from the primary decision maker related to the patient.
Study population:
A total of 80 patients of septic shock admitted in ICU will be enrolled into this study. Patients either admitted with septic shock or who develop septic shock during their stay in ICU will be eligible for inclusion into the study. The statin and placebo group will have 40 patients each.
- Conditions
- Septic Shock
- Being tested
- Atorvastatin, Placebo
- Keywords
- Statins, Septic Shock
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin or placebo given for 7 days to patients of septic shock admitted to ICU
PlaceboDrug
Equally matched placebo for 7 days to patients of septic shock admitted to ICU
| Study group | Role | What they receive |
|---|---|---|
| Statin | Active comparator | Atorvastatin, 40 mg for 7 days in patients of septic shock admitted to ICU Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | Matched placebo, 40 mg for 7 days in patients of septic shock admitted to ICU Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
28 day mortality after inclusion in study.
Measured: 28 day of ICU stay
Secondary outcomes (6)
Cytokines in septic shock
IL-6, TNF-α levels on Day 1, 4 and 7.
Measured: Day 1, 4 and 7 of commencement of trial drug.
Vasopressor free days.
Vasopressor free days during septic shock.
Measured: 28 days after commencement of trial drug.
Ventilation free days.
Ventilation free days during septic shock.
Measured: 28 days after commencement of trial drug.
Renal replacement free days.
Renal replacement free days during septic shock.
Measured: 28 days after commencement of trial drug.
Transfusion free days.
Transfusion free days during septic shock.
Measured: 28 days after commencement of trial drug.
Total parenteral nutrition free days.
Total parenteral nutrition free days during septic shock.
Measured: 28 days after commencement of trial drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startJan 2012
- Primary completionOct 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ratender K Singh, MD., Principal investigator, Sanjay Gandhi Post Graduate Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681653
- Sponsor's protocol ID
- PGI/IMP/IEC/56/19.08.2011
- Status last verified
- Dec 2015
- First submitted
- 15 Sep 2015
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29142375
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study to Assess Impact of Statins in Septic Shock
- ClinicalTrials.gov ID
- NCT02681653
- Acronym / sponsor ID
- PGI/IMP/IEC/56/19.08.2011
- Conditions
- Septic Shock
- Keywords
- Statins, Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- Jan 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
- Study impact of statins on levels of biomarkers (IL-6 and TNF-α) of sepsis.
- Study survival benefit of statins in septic shock.
Introduction:
Sepsis is the leading cause of mortality in non-coronary ICUs. Mortality associated with sepsis is still considerably high. Rising economic burden of managing sepsis is a major concern. Statin is an anti-hyperlipidemic drug with pleiotropic effects. It has properties like anti-inflammatory/oxidative, immunomodulatory effects, enhances endothelial function, reduction in blood thrombogenicity, and increased nitric oxide (NO) bioavailability. Available evidence suggests that statins may play a positive role in reduction of mortality in sepsis. However, the multidimensional heterogeneous character of the available studies does not allow drawing firm conclusions about its usefulness in sepsis and septic shock. This randomized, double blinded, placebo controlled trial is an attempt to study the impact of statins on mortality and biomarker levels in septic shock.
Details of material and methods:
Patients >= age 18 yrs meeting the American European consensus conference definition of septic shock will be enrolled into the study. After the written informed consent from the primary decision maker the patients will be randomized into either the drug or placebo group. Each group will either receive Atorvastatin 40mg or a matched placebo for 7 days. IL-6 and TNF alpha levels will be estimated on D1, D4 and D7 of the trial week. Relevant clinical and laboratory (clinical biochemistry, hematological, coagulation parameters, LFT and renal function tests) will be recorded simultaneously. Severity scores, event free days (vasopressor, ventilation, dialysis, transfusion, parenteral nutrition), and mortality after 28 days of inclusion in study will be recorded.
Ethical Issues:
Written informed consent will be taken from either the patient (if possible) or from the primary decision maker related to the patient.
Study population:
A total of 80 patients of septic shock admitted in ICU will be enrolled into this study. Patients either admitted with septic shock or who develop septic shock during their stay in ICU will be eligible for inclusion into the study. The statin and placebo group will have 40 patients each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin | Active comparator | Drug: AtorvastatinAtorvastatin, 40 mg for 7 days in patients of septic shock admitted to ICU |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo, 40 mg for 7 days in patients of septic shock admitted to ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical disease of septic shock
- Aged eighteen years and above
- Admitted to ICU
Key exclusion criteria (4 listed)
- Previous statin induced myopathy or hypersensitivity reaction
- Greater than two and half times elevated liver transaminases
- Chronic liver disease
- Pregnant or lactating mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAtorvastatin or placebo given for 7 days to patients of septic shock admitted to ICU | Drug | Statin |
| PlaceboEqually matched placebo for 7 days to patients of septic shock admitted to ICU | Drug | Placebo |
Primary outcome
Mortality
Time frame: 28 day of ICU stay
28 day mortality after inclusion in study.
6 secondary outcomes
Cytokines in septic shock
Time frame: Day 1, 4 and 7 of commencement of trial drug.
Vasopressor free days.
Time frame: 28 days after commencement of trial drug.
Ventilation free days.
Time frame: 28 days after commencement of trial drug.
Renal replacement free days.
Time frame: 28 days after commencement of trial drug.
Transfusion free days.
Time frame: 28 days after commencement of trial drug.
Total parenteral nutrition free days.
Time frame: 28 days after commencement of trial drug.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Derived from this study: PubMed 29142375Singh 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.
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ratender K Singh, MD. principal investigator
Sanjay Gandhi Post Graduate Institute of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin in people with Septic Shock, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 2 sites in India.
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 3 inclusion and 4 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 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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. Some participants in this study may receive a placebo. 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?
Mortality (time frame: 28 day of ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681653, which also lists 1 linked publication.
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 12 Feb 2016.