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CompletedNCT00692627PRiSMUpdated Jan 22, 2015

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

An observational study in Severe Falciparum Malaria, sponsored by University of Oxford. Completed at 1 site in Bangladesh. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-01-22.

Sponsored by University of Oxford · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Severe Falciparum Malaria

Keywords

  • Falciparum
  • malaria
  • volume
  • haemodynamics
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In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's planned enrollment of 80 is below the median of 600 across 218 observational studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
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

Exclusion Criteria

  1. Patients or relatives unable or unwilling to give informed consent.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (estimated)
06

What researchers measure

Primary outcomes

  1. Metabolic Acidosis

    Time frame: 48 hours

Secondary outcomes

  1. Acute renal failure

    Time frame: By discharge

  2. Acute pulmonary oedema

    Time frame: By discharge

07

Study locations

1 site
  • Chittagong Medical College Hospital
    Chittagong, Bangladesh
08

References and documents

Publications

  • Hanson J, Lam SW, Alam S, Pattnaik R, Mahanta KC, Uddin Hasan M, Mohanty S, Mishra S, Cohen S, Day N, White N, Dondorp A. The reliability of the physical examination to guide fluid therapy in adults with severe falciparum malaria: an observational study. Malar J. 2013 Oct 1;12:348. doi: 10.1186/1475-2875-12-348. PubMed 24079262 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00692627
Lead sponsor
University of Oxford
First posted
Jun 6, 2008
Start date
Jul 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Jan 22, 2015

Study contacts

Arjen Dondorp, MD
study director · Mahidol Oxford Research Unit

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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