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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692627
First Posted: June 6, 2008
Last Update Posted: January 22, 2015
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.
Information provided by:
University of Oxford
  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:

  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
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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

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

Secondary Outcome Measures:
  • Acute renal failure [ Time Frame: By discharge ]
  • Acute pulmonary oedema [ Time Frame: By discharge ]

Estimated Enrollment: 80
Study Start Date: July 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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

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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00692627


Locations
Bangladesh
Chittagong Medical College Hospital
Chittagong, Bangladesh
Sponsors and Collaborators
University of Oxford
Investigators
Study Director: Arjen Dondorp, MD Mahidol Oxford Research Unit
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Josh Hanson, Mahidol Oxford Research Unit
ClinicalTrials.gov Identifier: NCT00692627     History of Changes
Other Study ID Numbers: BKMAL0804
First Submitted: June 3, 2008
First Posted: June 6, 2008
Last Update Posted: January 22, 2015
Last Verified: January 2010

Keywords provided by University of Oxford:
Falciparum
malaria
volume
haemodynamics

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases