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

NCT ID: NCT00692627

Last Updated: 2015-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Falciparum Malaria

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Mahidol Oxford Research Unit

Principal Investigators

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Arjen Dondorp, MD

Role: STUDY_DIRECTOR

Mahidol Oxford Tropical Medicine Research Unit

Locations

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Chittagong Medical College Hospital

Chittagong, , Bangladesh

Site Status

Countries

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Bangladesh

References

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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.

Reference Type DERIVED
PMID: 24079262 (View on PubMed)

Other Identifiers

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BKMAL0804

Identifier Type: -

Identifier Source: org_study_id

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