COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Evaluation of Volume Status, Haemodynamics and Microcirculatory Flow in Adult Patients With Severe Falciparum Malaria (PRiSM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00692627
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : January 22, 2015
Information provided by:
University of Oxford

Brief Summary:

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:

  1. Assess the degree of hypovolaemia in adults with severe malaria and its contribution to microcirculatory dysfunction and acidosis.
  2. To assess the relationships between volume status, haemodynamic parameters and the renal and pulmonary manifestations of severe malaria.
  3. To assess the utility of central venous pressure measurement as a guide for fluid administration in patients with severe malaria
  4. 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 or disease
Severe Falciparum Malaria

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Volume Status, Haemodynamics and Microcirculatory Flow in Adult Patients With Severe Falciparum Malaria
Study Start Date : July 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Primary Outcome Measures :
  1. Metabolic Acidosis [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Acute renal failure [ Time Frame: By discharge ]
  2. Acute pulmonary oedema [ Time Frame: By discharge ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe Falciparum Malaria

Inclusion Criteria

  1. 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.
  2. The patients or their attending relative able and willing to give fully informed written consent.
  3. Age ≥ 16 years

Exclusion Criteria

1. Patients or relatives unable or unwilling to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00692627

Layout table for location information
Chittagong Medical College Hospital
Chittagong, Bangladesh
Sponsors and Collaborators
University of Oxford
Layout table for investigator information
Study Director: Arjen Dondorp, MD Mahidol Oxford Research Unit
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Josh Hanson, Mahidol Oxford Research Unit Identifier: NCT00692627    
Other Study ID Numbers: BKMAL0804
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2010
Keywords provided by University of Oxford:
Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases