Optimal Fluid Management in Adult Severe Malaria

NCT01936766 | Completed

• 1 other identifier: BAKMAL 1302
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malaria; Sepsis

Keywords

malaria, falciparum; sepsis; fluid therapy; thermodilution; extravascular lung water; acute kidney injury

Outcome Measures

Primary Outcomes (1)

• Association between the mean Global End-Diastolic Volume Index and serum creatine level and extravascular lung water index

  The association between the mean Global End-Diastolic Volume Index (GEDVI) over the first 24 hours and (1) serum creatinine level, and (2) Extravascular Lung Water Index (EVLWI)

  24 hours

Secondary Outcomes (11)

• Association between the GEDVI,after conventional fluid resuscitation, and (1) serum creatinine level, (2) EVLWI

  24 hours

• Correlation between GEDVI and changes over time in plasma lactate level

  72 hours

• Change in central venous oxygen saturation (ScvO2) in relation to GEDVI and its association with acid-base status

  72 hours

• Incidence of pulmonary edema and ALI/ARDS

  72 hours

• Incidence of AKI and induction rate of renal replacement therapy

  72 hours

Eligibility Criteria

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

Study Population

Patients with severe malaria or severe sepsis admitted to the secondary or tertiary care center

You may qualify if:

• A. Severe Malaria
• Any level of asexual form of P. falciparum parasitemia on blood smear
• Severe malaria with one or more of the following:
• i. Cerebral malaria (GCS \< 11). ii. Renal impairment (Creatinine \> 2mg/dL or Anuria) iii. Hypoglycaemia (Glucose \< 40mg/dL) iv. Systolic blood pressure \< 80mmHg with cool extremities v. Pulmonary edema vi. Venous bicarbonate \< 15mmol/L vii. Venous lactate \> 4mmol/L
• Age 16-65 years
• Written informed consent obtained from patient or attending relative.
• B. Severe Sepsis
• Negative blood smear for any Plasmodium species
• Clinical signs of infection with two of following:
• i. Heart rate \> 90/min ii. Respiratory rate \> 20/min iii. Body temperature \>38°C or \<36°C iv. White blood cell count of \> 12000/μL or \< 4000/μL
• Severe sepsis with one or more of the following due to infection:
• i. Systolic blood pressure \< 90mmHg despite fluid resuscitation ii. Lactate \> 4mmol/L iii. Urine output \< 0.5mL/kg/hour for \> 2 hours despite fluid resuscitation iv. Acute lung injury with PaO2/FiO2 \< 250 in the absence of pneumonia v. Acute lung injury with PaO2/FiO2 \< 200 in the presence of pneumonia vi. Creatinine \> 2mg/dL vii. Bilirubin \> 2mg/dL viii. Platelet count \< 100000/μL
• Age 16-65 years
• Written informed consent obtained from patient or attending relative

You may not qualify if:

• A. Severe Malaria
• Patient or relative unable or unwilling to give informed consent
• Spontaneous bleeding or platelet count \< 30000/μL on enrollment
• Pregnancy.
• Contraindication or unsuitable condition for thermodilution technique
• B. Severe Sepsis
• Patient or relative unable or unwilling to give informed consent
• Spontaneous bleeding or platelet count \< 30000/μL on enrollment
• Pregnancy.
• Contraindication or unsuitable condition for thermodilution technique

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Chittagong Medical College Hosiptal

Chittagong, Bangladesh

Location

MeSH Terms

Conditions

Malaria; Sepsis; Malaria, Falciparum; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Arjen Dondorp, MD

  Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 6, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

BA (1)