Status:
COMPLETED
Hylenex-Assisted Resuscitation in Kenya (HARK) Trial for the Management of Dehydration
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Dehydration
Eligibility:
All Genders
1+ years
Phase:
PHASE2
Brief Summary
One of the leading health issues among patients, particularly children, presenting for care in low- and middle-income countries is dehydration. When oral rehydration is not sufficient or is clinically...
Detailed Description
Subcutaneous (SC) infusion has been established in high-income countries as a safe and effective alternative to expedite and simplify IV access. , A study from 2003 demonstrated the efficacy of SC hyd...
Eligibility Criteria
Inclusion
- All patients presenting to a participating facility with moderate-to-severe dehydration will be considered for participation. Other inclusion criteria will include:
- Patients over the age of 1 month
- Patients presenting with moderate-to-severe dehydration who failed to improve or are not candidates for oral rehydration therapy and IV access is not successful twice
- Parents or legal guardian(s) available to provide written informed consent
Exclusion
- There will be no limitation based on race, tribe, language, or sexual orientation in the study for any patients who meet treatment criteria. There are no exclusions based on language. Exclusion criteria will include:
- Any condition precluding SC infusion or infusion-site evaluation in all possible anatomic locations, including the upper back, anterior thighs, abdomen, and other potential areas for hSC therapy
- Any reason (before study enrollment) for a hospital admission or extended stay for other than dehydration-related illness
- Known hypersensitivity to hyaluronidase or any ingredient in the study formulation of recombinant human hyaluronidase
- Any patient not eligible for IV or SC fluids as determined by the local clinician
- Any medical condition likely to interfere with the patient's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the patient's need for medical attention beyond that required for addressing the dehydration-related illness
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT02265575
Start Date
October 1 2014
End Date
December 1 2016
Last Update
March 7 2019
Active Locations (1)
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1
Sagam Community Hospital
Luanda, Kenya