Severe SepsisPERFuSENCT03641534
Monitoring of Perfusion in Sepsis and Malaria
An observational study of Severe Sepsis and Malaria, run by University of Oxford at 1 site in Bangladesh.
Trial summary
Sepsis and severe malaria together contribute to an estimated 13 million deaths annually, a great burden of which is in low-income countries. Optimal fluid management is critical yet remains one of the most challenging clinical care elements as volume overload precipitates pulmonary edema and volume restriction may… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Severe Sepsis, Malaria
- What is being tested?
- Lung Ultrasound examination, Compression ultrasonography (CUS) and Echocardiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 103 participants
- Where
- 1 siteBangladesh
- Study dates
- 4 Jun 2018to 26 Sep 2019
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male or female subjects, aged ≥12 years hospitalized with malaria or sepsis.
Who may be able to join
- Sepsis criteria:
- The sepsis criteria include the severe sepsis and septic shock categories according to 2012 Surviving Sepsis Campaign guidelines. Due to a possible delay in obtaining all the enrolment sequential organ failure assessment (SOFA) score variables necessary to fulfil the criteria for the latest 2016 sepsis definition, the 2012 Surviving Sepsis Campaign criteria and the quick SOFA tool will be used for inclusion. However, after study completion, when all admission SOFA scores will be available, all patients will be re-scored according to the Sepsis 3 definition.
- Documented or suspected infection
- Systolic blood pressure ≤ 100 mmHg, or receiving vasopressor (epinephrine, norepinephrine, dopamine)
- PLUS one or more of the following:
- Respiratory rate ≥22 breaths per minute or under oxygen therapy or mechanical ventilation B. Altered mental status (Glasgow Coma Scale ≤ 14)
Show all 22Show fewer
- Fully informed written consent obtained, including written informed consent from a relative or parent/guardian in case of reduced consciousness and/or age < 16 years.
- Age ≥12 years
- Negative peripheral blood slide for any stages of malaria parasites and a negative rapid diagnostic test (RDT) for falciparum and vivax malaria.
- Within 24 hours of hospital or ICU admission
- Note: Positive blood or urine cultures not required as eligibility criteria due to limited microbiology laboratory availability.
- Severe malaria criteria Using modified World Health Organization criteria for severe falciparum malaria, as defined previously.
- Any P. falciparum or P. vivax parasitaemia in adults, detected by asexual stages on a peripheral blood- slide or a positive RDT in combination with one or more:
- GCS <11 ii. Hematocrit < 20% with parasite count >100,000/mm3 iii. Jaundice with parasite count >100,000/mm3 iv. Serum creatinine >3 mg/dL (or anuria) v. Hypoglycemia with venous glucose <40 mg/dL vi. Systolic blood pressure <80 mmHg with cool extremities vii. Peripheral asexual stage parasitemia >10 % viii. Peripheral venous lactate >4 mmol/L ix. Peripheral venous bicarbonate <15 mmol/L x. Respiratory distress/pulmonary edema: radiologically confirmed, or oxygen saturation <92% on room air with a respiratory rate >30/min, often with chest indrawing and crepitations on auscultation xi. Spontaneous bleeding xii. Generalized convulsions (≥2 in 24 hours)
- Fully informed written consent obtained, including written informed consent from relative or parent/guardian in case of reduced consciousness and/or age < 16 years.
- Age ≥12 years
- Within 24 hours of antimalarial treatment
- Uncomplicated malaria criteria (control group)
- P. falciparum slide positive (asexual stages) on peripheral blood slide or positive RDT in combination with none of the above severity criteria.
- Within 24 hours of start of antimalarial treatment
- Fully informed written consent obtained, including written informed consent from relative or parent/guardian in case of reduced consciousness and/or age < 16 years.
- Age ≥12 years
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Patients admitted with known malignancy or liver disease
- Recent surgery (as part of current admission)
- Trauma (resulting in current admission)
- Antimalarial treatment ≥24 hours prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perfusion and Lung Congestion Evaluation Related to Fluids and Vasopressors in Sepsis and Malaria. (PERFuSE): an Observational Study
Sepsis and severe malaria together contribute to an estimated 13 million deaths annually, a great burden of which is in low-income countries. Optimal fluid management is critical yet remains one of the most challenging clinical care elements as volume overload precipitates pulmonary edema and volume restriction may exacerbate acute kidney injury. These complications of sepsis and severe malaria significantly increase mortality, particularly in resource-limited settings lacking mechanical ventilation and renal replacement therapy. Point-of-care ultrasound and passive leg raise testing are two easily implementable, safe and non-invasive clinical bedside fluid assessment tools that could be applied towards developing a fluid management algorithm in low resource settings. Similarly, simple tissue perfusion measures can facilitate understanding of precise indications or contraindication to fluid and vasopressor therapy.
However, the performance of these tools has yet to be confirmed in these settings. Accurate assessment of pulmonary tolerance and fluid responsive patients could aid to tailor vasopressor and fluid therapy to the patient condition and disease phase, thus preventing or detecting iatrogenic pulmonary edema and other pulmonary complications. As there is currently limited evidence supporting fluid management recommendations for severe malaria and sepsis in low-resource settings, the potential application of these management tools could optimize supportive therapy and improve outcomes in these populations.
Read more
The main activity proposed is a prospective, observational study of patients with sepsis and severe malaria to describe the relationship between fluid therapy and vasopressor therapy against measures of tissue perfusion and pulmonary congestion in adult patients with severe malaria or severe sepsis. In addition, the study will assess the performance of simple bedside clinical tools assessing fluid responsiveness, pulmonary congestion and peripheral tissue perfusion.
The data from this observational study will facilitate the preparation of a follow-up study to test a clinical algorithm to guide individualized fluid and vasopressor administration.
Read the detailed description
This will be a single center, prospective, longitudinal, observational study of patients with sepsis or severe malaria. It is planned that this initial observational study will inform a follow-up intervention study, based on the observational study findings (Lung Ultrasound and Passive Leg Raising- guided Vasopressors and Fluid Management in Patients with Sepsis and Severe Malaria). The follow-up study will propose testing of a clinical algorithm to individualize titration of vasopressors, diuretics and fluids based on the simple tools evaluated during the observational study.
The expected duration of study patient participation is 30 days. Patients will be assessed every 6 hours until fever clearance, parasite clearance (in malaria patients) and GCS normalization (score of 15) on two consecutive assessments. Thereafter, patients will be assessed daily until discharge or death with one follow-up visit at 14 days and a follow-up call at day 30. The prospective, observational recruitment phase of the study is expected to last 15 months.
Funder: Wellcome Trust of Great Britain, Grant reference number: 220211/A/20/Z
- Conditions
- Severe Sepsis, Malaria
- Being tested
- Lung Ultrasound examination, Compression ultrasonography (CUS), Echocardiography, Inferior Vena Cava ultrasound, Passive leg raising test (PLR)
- Keywords
- Perfusion, Lung congestion
- Medical subject headings
- Sepsis, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Ultrasound examinationProcedure or surgery
Use of lung ultrasound to detect pulmonary complications
Compression ultrasonography (CUS)Procedure or surgery
CUS is a highly sensitive and specific modality used to recognize lower extremity deep venous thrombosis (DVT)
EchocardiographyProcedure or surgery
Echocardiogram can be (i) identify imminent life-threatening causes of hemodynamic failure, (ii) recognize coexisting diagnoses that complicate management, (iii) follow the evolution of the disease process, and (iv) monitor response to treatment
Inferior Vena Cava ultrasoundProcedure or surgery
Measurement of the inferior vena cava diameter
Passive leg raising test (PLR)Procedure or surgery
Baseline assessment (including pulse rate, systolic and diastolic blood pressure, velocity time integral (VTI) and stroke volume (SV) echocardiographic measurements) will be performed in the resting semi-recumbent position, defined as a position with the trunk elevated 30° to 45° relative to the lower limbs.
Orthogonal polarization spectral imaging (OPS)Procedure or surgery
Measurement of capillary flow in the rectal microcirculation
Urine collection (Foley catheter)Procedure or surgery
For urinalysis, biochemistry, urine microscopy, pH, and culture.
Venous blood samplingsProcedure or surgery
for: parasitological and microbiological diagnostics, complete blood count, biochemistry, red cell deformability analyzed by laser assisted rotational cell analyser (LORCA), markers of oxidative stress (peripheral intravenous catheter)
ElectrocardiogramProcedure or surgery
all patients will have an ECG performed on enrolment as a non-invasive investigation
GlycoCheckProcedure or surgery
GlycoCheck is a clinical sublingual handheld, bedside microscope that detects erythrocytes within the small sublingual blood vessels measuring 5 to 25 micrometers in diameter. The sublingual vasculature is a validated site for measuring thickness of the endothelial glycocalyx.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Not described Receives: Procedure: Lung Ultrasound examination; Procedure: Compression ultrasonography (CUS); Procedure: Echocardiography; Procedure: Inferior Vena Cava ultrasound; Procedure: Passive leg raising test (PLR); Procedure: Orthogonal polarization spectral imaging (OPS); Procedure: Urine collection (Foley catheter); Procedure: Venous blood samplings; Procedure: Electrocardiogram; Procedure: GlycoCheck | |
| Severe malaria | Not described Receives: Procedure: Lung Ultrasound examination; Procedure: Compression ultrasonography (CUS); Procedure: Echocardiography; Procedure: Inferior Vena Cava ultrasound; Procedure: Passive leg raising test (PLR); Procedure: Orthogonal polarization spectral imaging (OPS); Procedure: Urine collection (Foley catheter); Procedure: Venous blood samplings; Procedure: Electrocardiogram; Procedure: GlycoCheck | |
| Uncomplicated malaria | Not described Receives: Procedure: Lung Ultrasound examination; Procedure: Compression ultrasonography (CUS); Procedure: Echocardiography; Procedure: Inferior Vena Cava ultrasound; Procedure: Passive leg raising test (PLR); Procedure: Orthogonal polarization spectral imaging (OPS); Procedure: Urine collection (Foley catheter); Procedure: Venous blood samplings; Procedure: Electrocardiogram; Procedure: GlycoCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid balance volume at 24 hours
Fluid balance volume in milliliters calculated daily as inputs minus outputs.
Measured: On the first 24 hours from enrollment
Plasma lactate levels
Plasma venous lactate levels expressed in mmol/L
Measured: 72 hours
Vasopressor therapy
Expressed as dichotomous variable, use of any vasopressor during the first 72 hours.
Measured: 72 hours
Global ultrasound aeration score
The score ( range 0-36) is calculated over 12 lung zones where each zone is scored 0 to 3.
Measured: 72 hours
Fluid balance volume at 48 hours
Fluid balance volume in milliliters calculated daily as inputs minus outputs.
Measured: On the first 48 hours from enrollment
Fluid balance volume at 72 hours
Fluid balance volume in milliliters calculated daily as inputs minus outputs.
Measured: On the first 72 hours from enrollment
Secondary outcomes (17)
Plasma creatinine levels
Measured in millimoles per liter.
Measured: 48 hours
Positive chest X-ray for pulmonary edema (dichotomous variable)
Other measures evaluating pulmonary congestion
Measured: 72 hours
The ratio between pulse oxymetry hemoglobin saturation and the fraction of inspired oxygen (SpO2/FiO2 ratio).
Other measures evaluating pulmonary congestion
Measured: 72 hours
Proportion of fluid responsive patients
Fluid responsiveness is defined as a positive pulse pressure passive leg raise test (change in pulse pressure >10% after leg raise manouver) or cardiac output-guided passive leg raise test (change in cardiac output >10% after leg raise manouver). The passive leg raise test is performed both a standard maneuver (bed tilting) and a modified maneuver (manual leg raise).
Measured: 72 hours
Prolonged capillary refill time (dichotomous variable, defined as ≥3 seconds)
Other measures evaluating tissue perfusion
Measured: 72 hours
Skin mottling score (0-5)
Other measures evaluating tissue perfusion
Measured: 72 hours
Cardiac index (in liters per minute per square meter of body surface area)
Other measures evaluating tissue perfusion
Measured: 72 hours
Core-periphery temperature gradient(°C)
Other measures evaluating tissue perfusion
Measured: 72 hours
Proportion of patients at enrolment and during admission with a low cardiac index and hypoperfusion state.
Measured: 72 hours
Proportion of patients with microvasculature obstruction or abnormalities
Microvasculature obstruction and abnormalities are detected with orthogonal polarization spectral imaging (OPS); red cell deformability is studied by laser assisted rotational cell analyser (LORCA).
Measured: 24 hours
Proportion of patients that develop pulmonary edema and acute respiratory distress syndrome (ARDS).
Pulmonary edema is defined as the presence of 2 or more positive lung zones per hemithorax on the lung ultrasound. Acute respiratory distress syndrome is defined according to the Berlin Definition criteria.
Measured: 72 hours
Case fatality in first 30 days.
Measured: 30 days
Acute kidney injury (AKI)
Proportion of AKI as per Kidney Diseases Improving Global Outcomes definition: serum creatinine increase by ≥ 3 mg/dl within 48 hours, or serum creatinine increase by ≥ 1.5 times baseline, or urine volume <0.5 mg/kg/h for 6 hours. Outcome of AKI defined as renal recovery (time in days until creatinine returns to baseline).
Measured: At admission, up to day 14, and renal recovery by 30 days
Proportion of patients that develop lower extremity deep venous thrombosis.
Deep venous thrombosis is defined as a positive compressive ultrasonography on femoral or popliteal veins of lower limbs.
Measured: 72 hours
Microbiological etiology of sepsis.
Results of blood culture and organism identified in case of positive result
Measured: 72 hours
Number of patients with ARDS according to the Kigali Modification of the Berlin Definition of ARDS
Measured: 72 hours
Diagnostic performance measures (sensitivity, specificity, positive predictive value, negative predictive value) of the digital microscope with expert microscopy as the gold standard
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start4 Jun 2018
- Primary completion29 Aug 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, University of Amsterdam, University of British Columbia, Chittagong Medical College and Hospital, Malaria Research Group & Dev Care Foundation, Dhaka, Bangladesh, Beth Israel Deaconess Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641534
- Sponsor's protocol ID
- MAL18001
- Acronym
- PERFuSE
- Status last verified
- Sep 2020
- First submitted
- 29 May 2018
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion and Lung Congestion Evaluation Related to Fluids and Vasopressors in Sepsis and Malaria. (PERFuSE): an Observational Study
- ClinicalTrials.gov ID
- NCT03641534
- Acronym / sponsor ID
- PERFuSE / MAL18001
- Conditions
- Severe Sepsis, Malaria
- Keywords
- Perfusion, Lung congestion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, University of Amsterdam, University of British Columbia, Chittagong Medical College and Hospital, Malaria Research Group & Dev Care Foundation, Dhaka, Bangladesh, Beth Israel Deaconess Medical Center
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 22 Aug 2018 (actual)
- 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 and severe malaria together contribute to an estimated 13 million deaths annually, a great burden of which is in low-income countries. Optimal fluid management is critical yet remains one of the most challenging clinical care elements as volume overload precipitates pulmonary edema and volume restriction may exacerbate acute kidney injury. These complications of sepsis and severe malaria significantly increase mortality, particularly in resource-limited settings lacking mechanical ventilation and renal replacement therapy. Point-of-care ultrasound and passive leg raise testing are two easily implementable, safe and non-invasive clinical bedside fluid assessment tools that could be applied towards developing a fluid management algorithm in low resource settings. Similarly, simple tissue perfusion measures can facilitate understanding of precise indications or contraindication to fluid and vasopressor therapy.
However, the performance of these tools has yet to be confirmed in these settings. Accurate assessment of pulmonary tolerance and fluid responsive patients could aid to tailor vasopressor and fluid therapy to the patient condition and disease phase, thus preventing or detecting iatrogenic pulmonary edema and other pulmonary complications. As there is currently limited evidence supporting fluid management recommendations for severe malaria and sepsis in low-resource settings, the potential application of these management tools could optimize supportive therapy and improve outcomes in these populations.
The main activity proposed is a prospective, observational study of patients with sepsis and severe malaria to describe the relationship between fluid therapy and vasopressor therapy against measures of tissue perfusion and pulmonary congestion in adult patients with severe malaria or severe sepsis. In addition, the study will assess the performance of simple bedside clinical tools assessing fluid responsiveness, pulmonary congestion and peripheral tissue perfusion.
The data from this observational study will facilitate the preparation of a follow-up study to test a clinical algorithm to guide individualized fluid and vasopressor administration.
Detailed description
This will be a single center, prospective, longitudinal, observational study of patients with sepsis or severe malaria. It is planned that this initial observational study will inform a follow-up intervention study, based on the observational study findings (Lung Ultrasound and Passive Leg Raising- guided Vasopressors and Fluid Management in Patients with Sepsis and Severe Malaria). The follow-up study will propose testing of a clinical algorithm to individualize titration of vasopressors, diuretics and fluids based on the simple tools evaluated during the observational study.
The expected duration of study patient participation is 30 days. Patients will be assessed every 6 hours until fever clearance, parasite clearance (in malaria patients) and GCS normalization (score of 15) on two consecutive assessments. Thereafter, patients will be assessed daily until discharge or death with one follow-up visit at 14 days and a follow-up call at day 30. The prospective, observational recruitment phase of the study is expected to last 15 months.
Funder: Wellcome Trust of Great Britain, Grant reference number: 220211/A/20/Z
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Procedure: Lung Ultrasound examination, Procedure: Compression ultrasonography (CUS), Procedure: Echocardiography, Procedure: Inferior Vena Cava ultrasound, Procedure: Passive leg raising test (PLR), Procedure: Orthogonal polarization spectral imaging (OPS), Procedure: Urine collection (Foley catheter), Procedure: Venous blood samplings, Procedure: Electrocardiogram, Procedure: GlycoCheck |
| Severe malaria | – | Procedure: Lung Ultrasound examination, Procedure: Compression ultrasonography (CUS), Procedure: Echocardiography, Procedure: Inferior Vena Cava ultrasound, Procedure: Passive leg raising test (PLR), Procedure: Orthogonal polarization spectral imaging (OPS), Procedure: Urine collection (Foley catheter), Procedure: Venous blood samplings, Procedure: Electrocardiogram, Procedure: GlycoCheck |
| Uncomplicated malaria | – | Procedure: Lung Ultrasound examination, Procedure: Compression ultrasonography (CUS), Procedure: Echocardiography, Procedure: Inferior Vena Cava ultrasound, Procedure: Passive leg raising test (PLR), Procedure: Orthogonal polarization spectral imaging (OPS), Procedure: Urine collection (Foley catheter), Procedure: Venous blood samplings, Procedure: Electrocardiogram, Procedure: GlycoCheck |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or female subjects, aged ≥12 years hospitalized with malaria or sepsis.
Key inclusion criteria (22 listed)
- Sepsis criteria:
- The sepsis criteria include the severe sepsis and septic shock categories according to 2012 Surviving Sepsis Campaign guidelines. Due to a possible delay in obtaining all the enrolment sequential organ failure assessment (SOFA) score variables necessary to fulfil the criteria for the latest 2016 sepsis definition, the 2012 Surviving Sepsis Campaign criteria and the quick SOFA tool will be used for inclusion. However, after study completion, when all admission SOFA scores will be available, all patients will be re-scored according to the Sepsis 3 definition.
- Documented or suspected infection
- Systolic blood pressure ≤ 100 mmHg, or receiving vasopressor (epinephrine, norepinephrine, dopamine)
- Fully informed written consent obtained, including written informed consent from a relative or parent/guardian in case of reduced consciousness and/or age < 16 years.
Key exclusion criteria (5 listed)
- Patients admitted with known malignancy or liver disease
- Recent surgery (as part of current admission)
- Trauma (resulting in current admission)
- Antimalarial treatment ≥24 hours prior to screening
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 |
|---|---|---|
| Lung Ultrasound examinationUse of lung ultrasound to detect pulmonary complications | Procedure or surgery | Sepsis, Severe malaria, Uncomplicated malaria |
| Compression ultrasonography (CUS)CUS is a highly sensitive and specific modality used to recognize lower extremity deep venous thrombosis (DVT) | Procedure or surgery | Sepsis, Severe malaria, Uncomplicated malaria |
| EchocardiographyEchocardiogram can be (i) identify imminent life-threatening causes of hemodynamic failure, (ii) recognize coexisting diagnoses that complicate management, (iii) follow the evolution of the disease process, and (iv) monitor response to treatment | Procedure or surgery | Sepsis, Severe malaria, Uncomplicated malaria |
| Inferior Vena Cava ultrasoundMeasurement of the inferior vena cava diameter | Procedure or surgery | Sepsis, Severe malaria, Uncomplicated malaria |
| Passive leg raising test (PLR)Baseline assessment (including pulse rate, systolic and diastolic blood pressure, velocity time integral (VTI) and stroke volume (SV) echocardiographic measurements) will be performed in the resting semi-recumbent position, defined as a position with the trunk elevated 30° to 45° relative to the lower limbs. | Procedure or surgery | Sepsis, Severe malaria, Uncomplicated malaria |
| Orthogonal polarization spectral imaging (OPS)Measurement of capillary flow in the rectal microcirculation | Procedure or surgery | Sepsis, Severe malaria, Uncomplicated malaria |
| Urine collection (Foley catheter)For urinalysis, biochemistry, urine microscopy, pH, and culture. | Procedure or surgery | Sepsis, Severe malaria, Uncomplicated malaria |
| Venous blood samplingsfor: parasitological and microbiological diagnostics, complete blood count, biochemistry, red cell deformability analyzed by laser assisted rotational cell analyser (LORCA), markers of oxidative stress (peripheral intravenous catheter) | Procedure or surgery | Sepsis, Severe malaria, Uncomplicated malaria |
| Electrocardiogramall patients will have an ECG performed on enrolment as a non-invasive investigation | Procedure or surgery | Sepsis, Severe malaria, Uncomplicated malaria |
| GlycoCheckGlycoCheck is a clinical sublingual handheld, bedside microscope that detects erythrocytes within the small sublingual blood vessels measuring 5 to 25 micrometers in diameter. The sublingual vasculature is a validated site for measuring thickness of the endothelial glycocalyx. | Procedure or surgery | Sepsis, Severe malaria, Uncomplicated malaria |
Primary outcome
Fluid balance volume at 24 hours
Time frame: On the first 24 hours from enrollment
Fluid balance volume in milliliters calculated daily as inputs minus outputs.
Plasma lactate levels
Time frame: 72 hours
Plasma venous lactate levels expressed in mmol/L
Vasopressor therapy
Time frame: 72 hours
Expressed as dichotomous variable, use of any vasopressor during the first 72 hours.
Global ultrasound aeration score
Time frame: 72 hours
The score ( range 0-36) is calculated over 12 lung zones where each zone is scored 0 to 3.
Fluid balance volume at 48 hours
Time frame: On the first 48 hours from enrollment
Fluid balance volume in milliliters calculated daily as inputs minus outputs.
Fluid balance volume at 72 hours
Time frame: On the first 72 hours from enrollment
Fluid balance volume in milliliters calculated daily as inputs minus outputs.
17 secondary outcomes
Plasma creatinine levels
Time frame: 48 hours
Positive chest X-ray for pulmonary edema (dichotomous variable)
Time frame: 72 hours
The ratio between pulse oxymetry hemoglobin saturation and the fraction of inspired oxygen (SpO2/FiO2 ratio).
Time frame: 72 hours
Proportion of fluid responsive patients
Time frame: 72 hours
Prolonged capillary refill time (dichotomous variable, defined as ≥3 seconds)
Time frame: 72 hours
Skin mottling score (0-5)
Time frame: 72 hours
Cardiac index (in liters per minute per square meter of body surface area)
Time frame: 72 hours
Core-periphery temperature gradient(°C)
Time frame: 72 hours
Proportion of patients at enrolment and during admission with a low cardiac index and hypoperfusion state.
Time frame: 72 hours
Proportion of patients with microvasculature obstruction or abnormalities
Time frame: 24 hours
Proportion of patients that develop pulmonary edema and acute respiratory distress syndrome (ARDS).
Time frame: 72 hours
Case fatality in first 30 days.
Time frame: 30 days
Acute kidney injury (AKI)
Time frame: At admission, up to day 14, and renal recovery by 30 days
Proportion of patients that develop lower extremity deep venous thrombosis.
Time frame: 72 hours
Microbiological etiology of sepsis.
Time frame: 72 hours
Number of patients with ARDS according to the Kigali Modification of the Berlin Definition of ARDS
Time frame: 72 hours
Diagnostic performance measures (sensitivity, specificity, positive predictive value, negative predictive value) of the digital microscope with expert microscopy as the gold standard
Time frame: 7 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 21 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Malaria, run by University of Oxford at 1 site in Bangladesh.
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 22 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 21 Jun 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 Bangladesh. 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?
Fluid balance volume at 24 hours (time frame: On the first 24 hours from enrollment). The study lists 6 primary outcomes in all. 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 21 Jun 2021.