SepsisSSSPNCT01449916
Simplified Severe Sepsis Protocol in Zambia
A study testing Simplified Severe Sepsis Protocol in people with Sepsis and Severe Sepsis, run by Vanderbilt University at 1 site in Zambia.
Trial summary
This study is a randomized control trial assessing the impact of a simple evidence-based protocol for the treatment severe sepsis in Zambia. The intervention protocol consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood transfusion when necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe Sepsis
- What is being tested?
- Simplified Severe Sepsis Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteZambia
- Study dates
- Feb 2012to Nov 2012
- 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
- Age 18 or older
- Suspected infection
- 2 or more of SIRS criteria:
- Heart rate >90/min
- Respiratory rate >20/min
- Temperature >= 38° C or <= 36° C
Show all 17Show fewer
- White blood count > 12,000 or < 4,000/µL
- 1 or more of the following signs of end-organ dysfunction
- Systolic blood pressure < 90 mm Hg
- Mean arterial blood pressure (MAP) < 65 mm Hg
- Confusion/altered mentation
- Urine output < 0.5 mL/kg/hr
- Creatinine increase > 0.5 mg/dL
- Creatinine > 0.5 mg/dL above upper limit of normal
- Platelet < 100x109/L
- Respiratory rate > 40/min
- Jaundice
Who cannot join
- GI bleed
- Need for urgent surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Sepsis Diagnosis and Treatment: Simplified Severe Sepsis Protocol (SSSP)
This study is a randomized control trial assessing the impact of a simple evidence-based protocol for the treatment severe sepsis in Zambia. The intervention protocol consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood transfusion when necessary. It is hypothesized that the protocol will significantly decrease in-hospital mortality in patients with severe sepsis.
Read the detailed description
In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. However, in sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Furthermore, although tuberculosis is a common cause of severe sepsis in the region, accurate and timely diagnosis of tuberculosis-associated severe sepsis remains elusive.
The aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis, (2) To evaluate the cost of implementation for a simplified severe sepsis protocol (3) To develop a clinical diagnostic score for identifying tuberculosis in HIV positive patients with severe sepsis (4) To assess the performance of the Xpert TB/RIF rapid PCR system for diagnosing tuberculosis in HIV positive patients with severe sepsis.
- Conditions
- Sepsis, Severe Sepsis
- Being tested
- Simplified Severe Sepsis Protocol
- Keywords
- Sepsis, Severe Sepsis, Protocol, Zambia
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified Severe Sepsis ProtocolOther
Early fluid protocol, early blood cultures and antibiotics; blood cultures and titrated dopamine in selected patients; monitoring based on vital signs and physical examination
| Study group | Role | What they receive |
|---|---|---|
| Simplified Severe Sepsis Protocol | Experimental | This protocol consists of an early aggressive fluid strategy, early blood cultures and antibiotics, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings. Receives: Other: Simplified Severe Sepsis Protocol |
| Usual care | Active comparator | Early blood cultures and antibiotics. Monitoring by study nurses as in experimental arm. Other interventions are according to admitting (non-study) doctors' orders. Receives: Other: Simplified Severe Sepsis Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital all cause mortality
Measured: During hospitalization, expected average 14 days
Secondary outcomes (6)
28-day all-cause mortality
Measured: 28-day
In-hospital all cause mortality adjusted for illness severity
Adjusted for SAPS3 score
Measured: During hospitalization, expected average 14 days
28-day all cause mortality adjusted for baseline illness severity
Adjusted for SAPS3 score
Measured: 28-day
Cumulative adverse events
A composite outcome consisting of dopamine extravasation, dopamine-associated tissue ischemia or necrosis, iatrogenic pulmonary oedema, and transfusion-related adverse events.
Measured: During hospitalization, expected average 14 days
Treatment cost per patient
A budget impact analysis will determine the cost of treatment per patient using a mix of direct measurements and micro-cost observation.
Measured: During hospitalization, expected average 14 days
Antibiotic changed due to culture results
The proportion of patients whose antibiotic regimen was changed due to information obtained from blood culture results.
Measured: During hospitalization, expected average 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionNov 2012
Why it stopped: High mortality rate in intervention arm for patients with RR \>40 AND SpO2 \< 90%.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Benjamin L Andrews, MD, Principal investigator, Vanderbilt University and University of Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449916
- Sponsor's protocol ID
- SSSP
- Other IDs
- R24TW007988
- Acronym
- SSSP
- Status last verified
- Sep 2021
- First submitted
- 5 Oct 2011
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sepsis Diagnosis and Treatment: Simplified Severe Sepsis Protocol (SSSP)
- ClinicalTrials.gov ID
- NCT01449916
- Acronym / sponsor ID
- SSSP / SSSP
- Conditions
- Sepsis, Severe Sepsis
- Keywords
- Sepsis, Severe Sepsis, Protocol, Zambia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High mortality rate in intervention arm for patients with RR \>40 AND SpO2 \< 90%.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- Feb 2012 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Oct 2011 (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.
This study is a randomized control trial assessing the impact of a simple evidence-based protocol for the treatment severe sepsis in Zambia. The intervention protocol consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood transfusion when necessary. It is hypothesized that the protocol will significantly decrease in-hospital mortality in patients with severe sepsis.
Detailed description
In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. However, in sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Furthermore, although tuberculosis is a common cause of severe sepsis in the region, accurate and timely diagnosis of tuberculosis-associated severe sepsis remains elusive.
The aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis, (2) To evaluate the cost of implementation for a simplified severe sepsis protocol (3) To develop a clinical diagnostic score for identifying tuberculosis in HIV positive patients with severe sepsis (4) To assess the performance of the Xpert TB/RIF rapid PCR system for diagnosing tuberculosis in HIV positive patients with severe sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simplified Severe Sepsis Protocol | Experimental | Other: Simplified Severe Sepsis ProtocolThis protocol consists of an early aggressive fluid strategy, early blood cultures and antibiotics, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings. |
| Usual care | Active comparator | Other: Simplified Severe Sepsis ProtocolEarly blood cultures and antibiotics. Monitoring by study nurses as in experimental arm. Other interventions are according to admitting (non-study) doctors' orders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 18 or older
- Suspected infection
- 2 or more of SIRS criteria:
- 1 or more of the following signs of end-organ dysfunction
Key exclusion criteria (2 listed)
- GI bleed
- Need for urgent surgery
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 |
|---|---|---|
| Simplified Severe Sepsis ProtocolEarly fluid protocol, early blood cultures and antibiotics; blood cultures and titrated dopamine in selected patients; monitoring based on vital signs and physical examination | Other | Simplified Severe Sepsis Protocol, Usual care |
Primary outcome
In-hospital all cause mortality
Time frame: During hospitalization, expected average 14 days
6 secondary outcomes
28-day all-cause mortality
Time frame: 28-day
In-hospital all cause mortality adjusted for illness severity
Time frame: During hospitalization, expected average 14 days
28-day all cause mortality adjusted for baseline illness severity
Time frame: 28-day
Cumulative adverse events
Time frame: During hospitalization, expected average 14 days
Treatment cost per patient
Time frame: During hospitalization, expected average 14 days
Antibiotic changed due to culture results
Time frame: During hospitalization, expected average 14 days
Results and safety
The study was stopped early (reason given: High mortality rate in intervention arm for patients with RR \>40 AND SpO2 \< 90%.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Benjamin L Andrews, MD principal investigator
Vanderbilt University and University of Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplified Severe Sepsis Protocol in people with Sepsis and Severe Sepsis, run by Vanderbilt University at 1 site in Zambia.
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 17 inclusion and 2 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: stopped early, as of the sponsor's last update on 30 Sep 2021. 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 Zambia. 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.
Are results available for this study?
The study was stopped early (reason given: High mortality rate in intervention arm for patients with RR \>40 AND SpO2 \< 90%.). Results are not available in the source record.
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?
In-hospital all cause mortality (time frame: During hospitalization, expected average 14 days). 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 30 Sep 2021.