drugset / Trial / NCT02265575

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

NCT02265575

Phase 2 Completed 51 enrolled Massachusetts General Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-10
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject rHuPH20 Protein / enzyme biologic Subcutaneous

Indications

No indication recorded.