SepsisNCT02346331
Epidemiology, Acute Management, and Outcomes of Patients With Sepsis Presenting to a Referral Hospital in Western Kenya
A study testing WHO algorithm of fluid boluses guided by physical examination, Frequent patient monitoring and Early administration of empiric antibiotics in people with Sepsis and Severe Sepsis, run by Duke University at 1 site in Kenya.
Trial summary
Sepsis is a clinical syndrome representing deranged hemodynamics (such as tachycardia) secondary to severe infection. In high-income countries (HICs), early resuscitation of septic patients with protocol-driven therapy, including quantitative fluid administration guided by invasive monitoring, has resulted in improved… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe Sepsis, Septic Shock
- What is being tested?
- WHO algorithm of fluid boluses guided by physical examination, Frequent patient monitoring and Early administration of empiric antibiotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2015to Sep 2016
- 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
- Presenting to MTRH Casualty Department for acute medical care
- Suspected infection, in the judgment of the managing clinician
- At least 2 of the following: axillary temperature >37.5°C or <35.5°C or core temperature >38.0°C or <36.0°C; heart rate >90 beats per minute; respiratory rate >20 breaths per minute; or systolic blood pressure <100 mmHg
Who cannot join
- Lack of basic language skills in either English or Kiswahili
- Pregnancy
- Congestive heart failure or valvular heart disease (as a known prior diagnosis or in the judgment of the managing clinician)
- Need for immediate surgery (within 6 hours) in the judgment of the managing clinician
- Inability to consent to study participation and lack of accompaniment by a family member or other surrogate who can provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Sepsis is a clinical syndrome representing deranged hemodynamics (such as tachycardia) secondary to severe infection. In high-income countries (HICs), early resuscitation of septic patients with protocol-driven therapy, including quantitative fluid administration guided by invasive monitoring, has resulted in improved outcomes for septic patients. Prevalence and mortality of sepsis are thought to be higher in sub-Saharan Africa (SSA) than in high-income countries; however, most hospitals in SSA lack the technology and resources necessary to implement the resuscitation protocols used in HICs and therefore, mortality from sepsis remains high. The World Health Organization (WHO) has recently disseminated an algorithm for resuscitation of septic patients in low resource settings. This algorithm is based on expert consensus only, and its efficacy has never been tested.
This study will be conducted in the Casualty Department of Moi Teaching and Referral Hospital (MTRH) in Eldoret, Kenya.
Read more
The purpose of this study is to describe the epidemiology of patients presenting with severe sepsis, to examine the microbiology causing severe sepsis, to describe current management and outcomes for severe sepsis, and to test the effect of implementation of the WHO resuscitation algorithm at MTRH.
The study design is a prospective before and after clinical trial. In an initial observational phase, adult patients presenting to the MTRH Casualty Department with sepsis and severe sepsis (the latter of which will be defined by elevated lactate) will be enrolled into a prospective observational cohort. Demographic data, medical characteristics, and microbiological studies will be obtained, then the management and outcomes of these patients will be observed. In a second phase, patients with sepsis will continue to be enrolled into a prospective observational cohort, while patients with severe sepsis will be enrolled into an intervention group. Patients in the intervention group will be managed according to the WHO resuscitation algorithm. Specifically, the WHO algorithm involves fluid boluses guided by vital signs and physical exam findings, rapid and early administration of empiric antibiotics, and frequent patient monitoring. The outcomes of interest are achievement of lactate clearance, which is a correlate of tissue perfusion, as well as 24-hour, in-hospital, and 30-day mortality.
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Being tested
- WHO algorithm of fluid boluses guided by physical examination, Frequent patient monitoring, Early administration of empiric antibiotics, Oxygen delivery, Correction of hypoglycemia
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO algorithm of fluid boluses guided by physical examinationOther
Frequent patient monitoringOther
Vital signs and physical exam every 30-60 minutes
Early administration of empiric antibioticsOther
Clinician will be prompted to administer antibiotics within 60 minutes
Oxygen deliveryOther
Correction of hypoglycemiaOther
If blood glucose is less than 3.0 mmol/L, IV dextrose will be administered
Correction of severe anemiaOther
If hemoglobin is less than 7 mg/dL, clinician will be prompted to offer blood transfusion
| Study group | Role | What they receive |
|---|---|---|
| WHO intervention | Experimental | This arm will be treated with the 2011 WHO sepsis recommendations for the first 6 hours of their hospitalization. The WHO recommendations involve fluid boluses guided by vital signs and physical exam, frequent patient monitoring, rapid and early administration of empiric antibiotics, oxygen delivery, correction of hypoglycemia, and correction of severe anemia. Receives: Other: WHO algorithm of fluid boluses guided by physical examination; Other: Frequent patient monitoring; Other: Early administration of empiric antibiotics; Other: Oxygen delivery; Other: Correction of hypoglycemia; Other: Correction of severe anemia |
| Standard care | No intervention | This arm will be managed per standard care by the hospital clinicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate clearance (difference in lactate [mmol/L] at study enrollment and 6 hours after study enrollment) as a measure of efficacy
Lactate level will be measured at study enrollment (time 0) and 6 hours after study enrollment (time 6). Lactate clearance will be reported as the difference between time 0 and time 6 lactate, as a fraction of time 0 lactate.
Measured: enrollment, 6 hours
Secondary outcomes (2)
Mortality
Measured: 24 hours, in-hospital, and 30 days
Number of subjects with adverse effects as a measure of safety
Measured: 6 hours, 24 hours, in-hospital, and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionSep 2016
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Moi University
- Responsible party
- Sponsor
- Investigators
- Nathan M Thielman, MD, MPH, Principal investigator, Duke UniversityCharles Kwobah, MBChB, MMed, Principal investigator, Moi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346331
- Sponsor's protocol ID
- Pro00056846
- Other IDs
- R25TW009337
- Status last verified
- Jan 2018
- First submitted
- 14 Jan 2015
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology, Acute Management, and Outcomes of Patients With Sepsis Presenting to a Referral Hospital in Western Kenya
- ClinicalTrials.gov ID
- NCT02346331
- Acronym / sponsor ID
- Pro00056846
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Moi University
- Study start
- Jan 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 Jan 2015 (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 clinical syndrome representing deranged hemodynamics (such as tachycardia) secondary to severe infection. In high-income countries (HICs), early resuscitation of septic patients with protocol-driven therapy, including quantitative fluid administration guided by invasive monitoring, has resulted in improved outcomes for septic patients. Prevalence and mortality of sepsis are thought to be higher in sub-Saharan Africa (SSA) than in high-income countries; however, most hospitals in SSA lack the technology and resources necessary to implement the resuscitation protocols used in HICs and therefore, mortality from sepsis remains high. The World Health Organization (WHO) has recently disseminated an algorithm for resuscitation of septic patients in low resource settings. This algorithm is based on expert consensus only, and its efficacy has never been tested.
This study will be conducted in the Casualty Department of Moi Teaching and Referral Hospital (MTRH) in Eldoret, Kenya.
The purpose of this study is to describe the epidemiology of patients presenting with severe sepsis, to examine the microbiology causing severe sepsis, to describe current management and outcomes for severe sepsis, and to test the effect of implementation of the WHO resuscitation algorithm at MTRH.
The study design is a prospective before and after clinical trial. In an initial observational phase, adult patients presenting to the MTRH Casualty Department with sepsis and severe sepsis (the latter of which will be defined by elevated lactate) will be enrolled into a prospective observational cohort. Demographic data, medical characteristics, and microbiological studies will be obtained, then the management and outcomes of these patients will be observed. In a second phase, patients with sepsis will continue to be enrolled into a prospective observational cohort, while patients with severe sepsis will be enrolled into an intervention group. Patients in the intervention group will be managed according to the WHO resuscitation algorithm. Specifically, the WHO algorithm involves fluid boluses guided by vital signs and physical exam findings, rapid and early administration of empiric antibiotics, and frequent patient monitoring. The outcomes of interest are achievement of lactate clearance, which is a correlate of tissue perfusion, as well as 24-hour, in-hospital, and 30-day mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHO intervention | Experimental | Other: WHO algorithm of fluid boluses guided by physical examination, Other: Frequent patient monitoring, Other: Early administration of empiric antibiotics, Other: Oxygen delivery, Other: Correction of hypoglycemia, Other: Correction of severe anemiaThis arm will be treated with the 2011 WHO sepsis recommendations for the first 6 hours of their hospitalization. The WHO recommendations involve fluid boluses guided by vital signs and physical exam, frequent patient monitoring, rapid and early administration of empiric antibiotics, oxygen delivery, correction of hypoglycemia, and correction of severe anemia. |
| Standard care | No intervention | –This arm will be managed per standard care by the hospital clinicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presenting to MTRH Casualty Department for acute medical care
- Suspected infection, in the judgment of the managing clinician
- At least 2 of the following: axillary temperature >37.5°C or <35.5°C or core temperature >38.0°C or <36.0°C; heart rate >90 beats per minute; respiratory rate >20 breaths per minute; or systolic blood pressure <100 mmHg
Key exclusion criteria (5 listed)
- Lack of basic language skills in either English or Kiswahili
- Pregnancy
- Congestive heart failure or valvular heart disease (as a known prior diagnosis or in the judgment of the managing clinician)
- Need for immediate surgery (within 6 hours) in the judgment of the managing clinician
- Inability to consent to study participation and lack of accompaniment by a family member or other surrogate who can provide consent
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 |
|---|---|---|
| WHO algorithm of fluid boluses guided by physical examination | Other | WHO intervention |
| Frequent patient monitoringVital signs and physical exam every 30-60 minutes | Other | WHO intervention |
| Early administration of empiric antibioticsClinician will be prompted to administer antibiotics within 60 minutes | Other | WHO intervention |
| Oxygen delivery | Other | WHO intervention |
| Correction of hypoglycemiaIf blood glucose is less than 3.0 mmol/L, IV dextrose will be administered | Other | WHO intervention |
| Correction of severe anemiaIf hemoglobin is less than 7 mg/dL, clinician will be prompted to offer blood transfusion | Other | WHO intervention |
Primary outcome
Lactate clearance (difference in lactate [mmol/L] at study enrollment and 6 hours after study enrollment) as a measure of efficacy
Time frame: enrollment, 6 hours
Lactate level will be measured at study enrollment (time 0) and 6 hours after study enrollment (time 6). Lactate clearance will be reported as the difference between time 0 and time 6 lactate, as a fraction of time 0 lactate.
2 secondary outcomes
Mortality
Time frame: 24 hours, in-hospital, and 30 days
Number of subjects with adverse effects as a measure of safety
Time frame: 6 hours, 24 hours, in-hospital, and 30 days
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 5 Jan 2018.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
Nathan M Thielman, MD, MPH principal investigator
Duke University
Charles Kwobah, MBChB, MMed principal investigator
Moi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO algorithm of fluid boluses guided by physical examination, Frequent patient monitoring and Early administration of empiric antibiotics in people with Sepsis and Severe Sepsis, run by Duke University at 1 site in Kenya.
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 5 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 5 Jan 2018. 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 Kenya. 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 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?
Lactate clearance (difference in lactate [mmol/L] at study enrollment and 6 hours after study enrollment) as a measure of efficacy (time frame: enrollment, 6 hours). 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 5 Jan 2018.