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OpenTrials
Completed

NCT Number: NCT00692627

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chittagong Medical College Hospital

Chittagong, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Acronym: PRiSM

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 6, 2008
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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