Critical IllnessPhase 3NCT02067949
Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient
A Phase 3 study testing Simvastatin in people with Critical Illness, run by sara mostafa amin eladawy at 1 site in Egypt.
Trial summary
determination of the effectiveness and the cost-effectiveness of simvastatin(Zocor 40 mg) plus standard therapy (SSCG)versus standard therapy alone in critically ill septic patient from the societal perspective over one year. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2014to Mar 2015
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and less than 70
- Sepsis for less than 24 hours from ICU admission
Who cannot join
- Elderly (defined as older than 70).
- Pediatrics (defined as younger than 18).
- Pregnancy and nursing.
- Unable to receive enteral medications.
- History of hypersensitivity to the trial drug.
- Are receiving drugs known to interact with simvastatin.
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- Acute liver failure and chronic liver disease (Child C).
- High risk of rhabdomyolysis (multiple traumas, crush injuries, extensive burns(>60%), baseline creatinine kinase (CK) ≥ten-times upper limit of normal.
- Patients with dyslipidemia or Prior statin user.
- Sever renal impairment (defined as need for replacement therapy )and uncontrolled hypothyroidism
- Have a history of known or suspected porphyria
- Are unlikely to survive more than 24 hours
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain shams university hospital and cairo university hospital
Cairo, Cairo Governorate, 11361
About this study
Official title: The Clinical Outcome and the Cost-effectiveness Analysis of Simvastatin Plus Standard Therapy Versus Standard Therapy Alone in Critically Ill Septic Patient"
determination of the effectiveness and the cost-effectiveness of simvastatin(Zocor 40 mg) plus standard therapy (SSCG)versus standard therapy alone in critically ill septic patient from the societal perspective over one year.
Read the detailed description
Prospective double blinded randomized controlled study Will be carried out at Ain-Shams university hospital Method: - After approval of the research ethics committee of Ain shams University and obtaining consent from each patient, 100 patients newly admitted to the intensive care unit (ICU) diagnosed to have sepsis/severe sepsis defined by American College of Chest Physicians (ACP) *will be randomized by the clinical pharmacist using a computer-generated randomization sequence with a block size of four into two groups.
Group I (Control group):-50 patients will be treated according to "Surviving Sepsis Campaign guidelines (SSCG) (Dellinger, et al. 2013) Group II (Intervention group):-50 patients will be treated according SSCG plus simvastatin.
Outcomes:- Primary outcome measures: 28 day ICU and hospital mortality.
Secondary Outcome Measures:
- Requirement and length of renal replacement therapy, vasoactive agent support or mechanical ventilation
- Total ICU length of stay.(LOS)
- Number of patients alive 3, 6, and 12 months
- Incremental cost effectiveness ratio
- Conditions
- Critical Illness
- Being tested
- Simvastatin
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor 40 mg
single oral tablet 40 mg / day If the patient is able to swallow; the tablet will be given orally. Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube
| Study group | Role | What they receive |
|---|---|---|
| broad spectrum AB +fluids | No intervention | Control group :50 patients will be treated according to SURVIVING SEPSIS CAMPAIGN BUNDLES |
| simvastatin | Active comparator | 50 patients will be treated according SSCG plus simvastatin as single oral tablet 40 mg / day begin with inclusion in the study and continue until hospital discharge .If the patient is able to swallow; the tablet will be given orally. Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube. (White R, Bradnam V, 2013) Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 day ICU and hospital mortality
Measured: one year
Secondary outcomes (1)
Number of patients alive 3, 6, and 12 months and incremental cost effectiveness ratio
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- sara mostafa amin eladawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sara mostafa amin eladawy, Ain Shams University
- Investigators
- sara M amin, MSC, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067949
- Sponsor's protocol ID
- 1/2014
- Status last verified
- Apr 2015
- First submitted
- 19 Feb 2014
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcome and the Cost-effectiveness Analysis of Simvastatin Plus Standard Therapy Versus Standard Therapy Alone in Critically Ill Septic Patient"
- ClinicalTrials.gov ID
- NCT02067949
- Acronym / sponsor ID
- 1/2014
- Conditions
- Critical Illness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- sara mostafa amin eladawyUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Feb 2014 (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.
determination of the effectiveness and the cost-effectiveness of simvastatin(Zocor 40 mg) plus standard therapy (SSCG)versus standard therapy alone in critically ill septic patient from the societal perspective over one year.
Detailed description
Prospective double blinded randomized controlled study Will be carried out at Ain-Shams university hospital Method: - After approval of the research ethics committee of Ain shams University and obtaining consent from each patient, 100 patients newly admitted to the intensive care unit (ICU) diagnosed to have sepsis/severe sepsis defined by American College of Chest Physicians (ACP) *will be randomized by the clinical pharmacist using a computer-generated randomization sequence with a block size of four into two groups.
Group I (Control group):-50 patients will be treated according to "Surviving Sepsis Campaign guidelines (SSCG) (Dellinger, et al. 2013) Group II (Intervention group):-50 patients will be treated according SSCG plus simvastatin.
Outcomes:- Primary outcome measures: 28 day ICU and hospital mortality.
Secondary Outcome Measures:
- Requirement and length of renal replacement therapy, vasoactive agent support or mechanical ventilation
- Total ICU length of stay.(LOS)
- Number of patients alive 3, 6, and 12 months
- Incremental cost effectiveness ratio
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| broad spectrum AB +fluids | No intervention | –Control group :50 patients will be treated according to SURVIVING SEPSIS CAMPAIGN BUNDLES |
| simvastatin | Active comparator | Drug: Simvastatin50 patients will be treated according SSCG plus simvastatin as single oral tablet 40 mg / day begin with inclusion in the study and continue until hospital discharge .If the patient is able to swallow; the tablet will be given orally. Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube. (White R, Bradnam V, 2013) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 and less than 70
- Sepsis for less than 24 hours from ICU admission
Key exclusion criteria (12 listed)
- Elderly (defined as older than 70).
- Pediatrics (defined as younger than 18).
- Pregnancy and nursing.
- Unable to receive enteral medications.
- History of hypersensitivity to the trial drug.
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 |
|---|---|---|
| SimvastatinAlso: Zocor 40 mgsingle oral tablet 40 mg / day If the patient is able to swallow; the tablet will be given orally. Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube | Drug | simvastatin |
Primary outcome
28 day ICU and hospital mortality
Time frame: one year
1 secondary outcome
Number of patients alive 3, 6, and 12 months and incremental cost effectiveness ratio
Time frame: one year
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 6 Apr 2015.
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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.
sara M amin, MSC principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Simvastatin in people with Critical Illness, run by sara mostafa amin eladawy at 1 site in Egypt.
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 2 inclusion and 12 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 6 Apr 2015. 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
28 day ICU and hospital mortality (time frame: one year). 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 6 Apr 2015.