Evaluation of Volume Status, Haemodynamics and Microcirculatory Flow in Adult Patients With Severe Falciparum Malaria (PRiSM)
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Severe Falciparum Malaria |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Evaluation of Volume Status, Haemodynamics and Microcirculatory Flow in Adult Patients With Severe Falciparum Malaria |
- Metabolic Acidosis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Acute renal failure [ Time Frame: By discharge ] [ Designated as safety issue: No ]
- Acute pulmonary oedema [ Time Frame: By discharge ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Severe Falciparum Malaria
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.
Contacts and Locations| Contact: Josh Hanson, MD | joshinthailand@gmail.com | |
| Contact: Arjen Dondorp, MD | arjen@tropmedres.ac |
| Bangladesh | |
| Chittagong Medical College Hospital | Recruiting |
| Chittagong, Bangladesh | |
| Contact: Ashraf Kabir, MD | |
| Contact: Emran Yunus, MD | |
| Study Director: | Arjen Dondorp, MD | Mahidol Oxford Research Unit |
More Information
No publications provided
| Responsible Party: | Josh Hanson, Mahidol Oxford Research Unit |
| ClinicalTrials.gov Identifier: | NCT00692627 History of Changes |
| Other Study ID Numbers: | BKMAL0804 |
| Study First Received: | June 3, 2008 |
| Last Updated: | January 21, 2010 |
| Health Authority: | Bangladesh: Bangladesh Medical Research Council |
Keywords provided by University of Oxford:
|
Falciparum malaria volume haemodynamics |
Additional relevant MeSH terms:
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013