Hylenex-Assisted Resuscitation in Kenya (HARK) Trial for the Management of Dehydration

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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 inappropriate, rehydration often occurs intravenously. An alternative to intravenous rehydration is subcutaneous infusion and - with or without hyaluronidase enzyme (or Hylenex) - has been shown in several robust trials in high-income countries to be as effective and even safer than intravenous infusion. In this study in western Kenya, the investigators propose a first-ever randomized controlled trial to evaluate whether hyaluronidase-facilitated subcutaneous infusion can be as effective and safe as IV therapy among moderate-to-severely dehydrated patients in low- and middle-income countries.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Hyaluronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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