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

NCT00692627 | Completed

• 1 other identifier: BKMAL0804
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 1.Assess the degree of hypovolaemia in adults with severe malaria and its contribution to microcirculatory dysfunction and acidosis.
2. 2.To assess the relationships between volume status, haemodynamic parameters and the renal and pulmonary manifestations of severe malaria.
3. 3.To assess the utility of central venous pressure measurement as a guide for fluid administration in patients with severe malaria
4. 4.To investigate the prognostic and clinical utility of central venous oxygen saturation in severe malaria

Conditions

Severe Falciparum Malaria

Keywords

Falciparum; malaria; volume; haemodynamics

Outcome Measures

Primary Outcomes (1)

• Metabolic Acidosis

  48 hours

Secondary Outcomes (2)

• Acute renal failure

  By discharge

• Acute pulmonary oedema

  By discharge

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Severe Falciparum Malaria

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Chittagong Medical College Hospital

Chittagong, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 24079262 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Arjen Dondorp, MD

  Mahidol Oxford Tropical Medicine Research Unit

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 6, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 22, 2015

Record last verified: 2010-01

Locations

BA (1)