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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Oxford.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00692627
First received: June 3, 2008
Last updated: January 21, 2010
Last verified: January 2010
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692627

Contacts
Contact: Josh Hanson, MD joshinthailand@gmail.com
Contact: Arjen Dondorp, MD arjen@tropmedres.ac

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

No publications provided by University of Oxford

Additional 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
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 September 14, 2014