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

Severe Falciparum Malaria Clinical Trial

— PRiSM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00692627
• Other study ID #: BKMAL0804
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: January 21, 2015
• Start date: July 2008
• Est. completion date: December 2008

Study information

• Verified date: January 2010
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Bangladesh Medical Research Council
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Severe Falciparum Malaria

Locations

Country	Name	City	State
Bangladesh	Chittagong Medical College Hospital	Chittagong

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Acidosis		48 hours	No
Secondary	Acute renal failure		By discharge	No
Secondary	Acute pulmonary oedema		By discharge	No