Study Results
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Basic Information
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COMPLETED
103 participants
OBSERVATIONAL
2018-06-04
2019-09-26
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Sepsis
Lung Ultrasound examination
Use of lung ultrasound to detect pulmonary complications
Compression ultrasonography (CUS)
CUS is a highly sensitive and specific modality used to recognize lower extremity deep venous thrombosis (DVT)
Echocardiography
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 ultrasound
Measurement of the inferior vena cava diameter
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.
Orthogonal polarization spectral imaging (OPS)
Measurement of capillary flow in the rectal microcirculation
Urine collection (Foley catheter)
For urinalysis, biochemistry, urine microscopy, pH, and culture.
Venous blood samplings
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)
Electrocardiogram
all patients will have an ECG performed on enrolment as a non-invasive investigation
GlycoCheck
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.
Severe malaria
Lung Ultrasound examination
Use of lung ultrasound to detect pulmonary complications
Compression ultrasonography (CUS)
CUS is a highly sensitive and specific modality used to recognize lower extremity deep venous thrombosis (DVT)
Echocardiography
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 ultrasound
Measurement of the inferior vena cava diameter
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.
Orthogonal polarization spectral imaging (OPS)
Measurement of capillary flow in the rectal microcirculation
Urine collection (Foley catheter)
For urinalysis, biochemistry, urine microscopy, pH, and culture.
Venous blood samplings
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)
Electrocardiogram
all patients will have an ECG performed on enrolment as a non-invasive investigation
GlycoCheck
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.
Uncomplicated malaria
Lung Ultrasound examination
Use of lung ultrasound to detect pulmonary complications
Compression ultrasonography (CUS)
CUS is a highly sensitive and specific modality used to recognize lower extremity deep venous thrombosis (DVT)
Echocardiography
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 ultrasound
Measurement of the inferior vena cava diameter
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.
Orthogonal polarization spectral imaging (OPS)
Measurement of capillary flow in the rectal microcirculation
Urine collection (Foley catheter)
For urinalysis, biochemistry, urine microscopy, pH, and culture.
Venous blood samplings
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)
Electrocardiogram
all patients will have an ECG performed on enrolment as a non-invasive investigation
GlycoCheck
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.
Interventions
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Lung Ultrasound examination
Use of lung ultrasound to detect pulmonary complications
Compression ultrasonography (CUS)
CUS is a highly sensitive and specific modality used to recognize lower extremity deep venous thrombosis (DVT)
Echocardiography
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 ultrasound
Measurement of the inferior vena cava diameter
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.
Orthogonal polarization spectral imaging (OPS)
Measurement of capillary flow in the rectal microcirculation
Urine collection (Foley catheter)
For urinalysis, biochemistry, urine microscopy, pH, and culture.
Venous blood samplings
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)
Electrocardiogram
all patients will have an ECG performed on enrolment as a non-invasive investigation
GlycoCheck
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.
Eligibility Criteria
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Inclusion 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.
1. Documented or suspected infection
2. Systolic blood pressure ≤ 100 mmHg, or receiving vasopressor (epinephrine, norepinephrine, dopamine)
PLUS one or more of the following:
A. Respiratory rate ≥22 breaths per minute or under oxygen therapy or mechanical ventilation B. Altered mental status (Glasgow Coma Scale ≤ 14)
3. 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.
4. Age ≥12 years
5. Negative peripheral blood slide for any stages of malaria parasites and a negative rapid diagnostic test (RDT) for falciparum and vivax malaria.
6. 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.
II. 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:
i. 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
III. 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
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Mahidol Oxford Tropical Medicine Research Unit
OTHER
University of Amsterdam
OTHER
University of British Columbia
OTHER
Chittagong Medical College and Hospital
OTHER
Malaria Research Group & Dev Care Foundation, Dhaka, Bangladesh
UNKNOWN
Beth Israel Deaconess Medical Center
OTHER
University of Oxford
OTHER
Responsible Party
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Locations
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Chittagong Medical College Hospital
Chittagong, , Bangladesh
Countries
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Other Identifiers
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MAL18001
Identifier Type: -
Identifier Source: org_study_id
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