Monitoring of Perfusion in Sepsis and Malaria

CompletedOBSERVATIONAL
Enrollment

103

Participants

Timeline

Start Date

June 4, 2018

Primary Completion Date

August 29, 2019

Study Completion Date

September 26, 2019

Conditions
Severe SepsisMalaria
Interventions
PROCEDURE

Lung Ultrasound examination

Use of lung ultrasound to detect pulmonary complications

PROCEDURE

Compression ultrasonography (CUS)

CUS is a highly sensitive and specific modality used to recognize lower extremity deep venous thrombosis (DVT)

PROCEDURE

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

PROCEDURE

Inferior Vena Cava ultrasound

Measurement of the inferior vena cava diameter

PROCEDURE

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

Orthogonal polarization spectral imaging (OPS)

Measurement of capillary flow in the rectal microcirculation

PROCEDURE

Urine collection (Foley catheter)

For urinalysis, biochemistry, urine microscopy, pH, and culture.

PROCEDURE

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)

PROCEDURE

Electrocardiogram

all patients will have an ECG performed on enrolment as a non-invasive investigation

PROCEDURE

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.

Trial Locations (1)

Unknown

Chittagong Medical College Hospital, Chittagong

All Listed Sponsors
collaborator

Mahidol Oxford Tropical Medicine Research Unit

OTHER

collaborator

University of Amsterdam

OTHER

collaborator

University of British Columbia

OTHER

collaborator

Chittagong Medical College and Hospital

OTHER

collaborator

Malaria Research Group & Dev Care Foundation, Dhaka, Bangladesh

UNKNOWN

collaborator

Beth Israel Deaconess Medical Center

OTHER

lead

University of Oxford

OTHER

NCT03641534 - Monitoring of Perfusion in Sepsis and Malaria | Biotech Hunter | Biotech Hunter