Optimal Fluid Management in Adult Severe Malaria (NCT01936766) | Clinical Trial Compass
CompletedNot Applicable
Optimal Fluid Management in Adult Severe Malaria
Bangladesh156 participantsStarted 2013-05
Plain-language summary
Optimal fluid therapy in severe falciparum malaria has not been well defined, especially in resource poor settings where access to mechanical ventilation is limited. Recent studies suggest that liberal fluid resuscitation is harmful for severe malaria patients despite they often being hypovolemic on admission. In order to elucidate the minimum fluid therapy required to prevent complications in severe malaria, we will conduct a prospective observational study in adults with severe malaria, and also in adults with severe sepsis as a comparison group. The objective of this study is to describe the association between hemodynamic variations in conventional fluid management and the probability of developing acute kidney injury (AKI) or pulmonary edema in adults with severe malaria and severe sepsis. Hemodynamic measurements will be obtained by using transpulmonary thermodilution and arterial pulse contour analysis.
Who can participate
Age range16 Years ā 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Any level of asexual form of P. falciparum parasitemia on blood smear
ā. Severe malaria with one or more of the following:
ā. Age 16-65 years
ā. Written informed consent obtained from patient or attending relative.
ā. Negative blood smear for any Plasmodium species
ā. Clinical signs of infection with two of following:
ā. Severe sepsis with one or more of the following due to infection:
ā. Age 16-65 years
Exclusion criteria
ā. Patient or relative unable or unwilling to give informed consent
ā. Serious pre-existing disease The following exclusion criteria described below are applied to patient for whom invasive hemodynamic monitoring will be performed.
What they're measuring
1
Association between the mean Global End-Diastolic Volume Index and serum creatine level and extravascular lung water index
. Spontaneous bleeding or platelet count \< 30000/Ī¼L on enrollment
ā. Pregnancy.
ā. Contraindication or unsuitable condition for thermodilution technique
ā. Patient or relative unable or unwilling to give informed consent
ā. Serious pre-existing disease The following exclusion criteria described below are applied to patient for whom invasive hemodynamic monitoring will be performed.
ā. Spontaneous bleeding or platelet count \< 30000/Ī¼L on enrollment