- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00692627
Evaluation of Volume Status, Haemodynamics and Microcirculatory Flow in Adult Patients With Severe Falciparum Malaria (PRiSM)
acidosis, acute renal failure and acute pulmonary oedema are common, and frequently fatal, manifestations of severe P. falciparum malaria. The course of all three might be ameliorated by optimising a patient's intravenous fluid therapy. The fluid treatment of severe malaria is presently empirical, by defining cardiovascular responses to volume replacement we would provide a physiological basis for resuscitation strategies.
We will use pulse contour cardiac output monitoring (PiCCOTM) to guide the fluid resuscitation of patients admitted to intensive care with severe malaria. With data collected during the patients' admission we hope to:
- Assess the degree of hypovolaemia in adults with severe malaria and its contribution to microcirculatory dysfunction and acidosis.
- To assess the relationships between volume status, haemodynamic parameters and the renal and pulmonary manifestations of severe malaria.
- To assess the utility of central venous pressure measurement as a guide for fluid administration in patients with severe malaria
- To investigate the prognostic and clinical utility of central venous oxygen saturation in severe malaria
In this way we hope to develop a greater understanding of the pathophysiology of haemodynamic derangement in severe malaria. By comparing the PiCCO derived data with simpler clinical parameters, we hope to determine potential fluid resuscitation strategies - relevant for a resource poor setting - whose efficacy could be confirmed in future trials.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Chittagong, Bangladesh
- Chittagong Medical College Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria
- Severe malaria, defined by the modified criteria of Hien et al and the presence of asexual forms of P. falciparum in the peripheral blood smear.
- The patients or their attending relative able and willing to give fully informed written consent.
- Age ≥ 16 years
Exclusion Criteria
1. Patients or relatives unable or unwilling to give informed consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Metabolic Acidosis
Time Frame: 48 hours
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48 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acute renal failure
Time Frame: By discharge
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By discharge
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Acute pulmonary oedema
Time Frame: By discharge
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By discharge
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Arjen Dondorp, MD, Mahidol Oxford Research Unit
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BKMAL0804
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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