Recombinant Human Hyaluronidase-Enabled Subcutaneous Pediatric Rehydration

被引:41
作者
Allen, Coburn H. [1 ,2 ]
Etzwiler, Lisa S. [3 ]
Miller, Melissa K. [4 ]
Maher, George [5 ]
Mace, Sharon [6 ]
Hostetler, Mark A. [7 ]
Smith, Sharon R. [8 ]
Reinhardt, Neil [9 ]
Hahn, Barry [10 ]
Harb, George [11 ]
机构
[1] Baylor Univ, Dept Pediat, Sect Emergency Med, Houston, TX 77030 USA
[2] Baylor Univ, Dept Pediat, Infect Dis Sect, Houston, TX 77030 USA
[3] St Johns Mercy Childrens Hosp, Dept Emergency Med, St Louis, MO USA
[4] Childrens Mercy Hosp, Emergency Med Serv, Kansas City, MO 64108 USA
[5] Childrens Mem Hosp, Pediat Hospitalist Serv, South Bend, IN USA
[6] Cleveland Clin, Dept Emergency Med, Cleveland, OH 44106 USA
[7] Univ Chicago, Dept Pediat, Chicago, IL 60637 USA
[8] Connecticut Childrens Med Ctr, Dept Pediat, Div Emergency Med, Hartford, CT USA
[9] Tampa Gen Hosp, Pediat Emergency Dept, Tampa, FL 33606 USA
[10] Staten Isl Univ Hosp, Dept Emergency Med, Staten Isl, NY USA
[11] Baxter Healthcare Corp, Dept Medicat Delivery, Deerfield, IL 60015 USA
关键词
rehydration; dehydration; hyaluronidase; pediatric; subcutaneous; INTRAVENOUS REHYDRATION; HYPODERMOCLYSIS; HYDRATION; INFUSION; CHILDREN;
D O I
10.1542/peds.2008-3588
中图分类号
R72 [儿科学];
学科分类号
100202 [儿科学];
摘要
OBJECTIVES: The Increased Flow Utilizing Subcutaneously-Enabled (INFUSE)-Pediatric Rehydration Study was designed to assess efficacy, safety, and clinical utility of recombinant human hyaluronidase (rHuPH20)-facilitated subcutaneous rehydration in children 2 months to 10 years of age. METHODS: Patients with mild/moderate dehydration requiring parenteral treatment in US emergency departments were eligible for this phase IV, multicenter, single-arm study. They received subcutaneous injection of 1 mL rHuPH20 (150 U), followed by subcutaneous infusion of 20 mL/kg isotonic fluid over the first hour. Subcutaneous rehydration was continued as needed for up to 72 hours. Rehydration was deemed successful if it was attributed by the investigator primarily to subcutaneous fluid infusion and the child was discharged without requiring an alternative method of rehydration. RESULTS: Efficacy was evaluated in 51 patients (mean age: 1.9 years; mean weight: 11.2 kg). Initial subcutaneous catheter placement was achieved with 1 attempt for 46/51 (90.2%) of patients. Rehydration was successful for 43/51 (84.3%) of patients. Five patients (9.8%) were hospitalized but deemed to be rehydrated primarily through subcutaneous therapy, for a total of 48/51 (94.1%) of patients. No treatment-related systemic adverse events were reported, but 1 serious adverse event occurred (cellulitis at infusion site). Investigators found the procedure easy to perform for 96% of patients (49/51 patients), and 90% of parents (43/48 parents) were satisfied or very satisfied. CONCLUSIONS: rHuPH20-facilitated subcutaneous hydration seems to be safe and effective for young children with mild/moderate dehydration. Subcutaneous access is achieved easily, and the procedure is well accepted by clinicians and parents. Pediatrics 2009; 124: e858-e867
引用
收藏
页码:E858 / E867
页数:10
相关论文
共 42 条
[1]
[Anonymous], 2006, TREATM DIARRH MAN PH
[2]
[Anonymous], WHALEY WONGS ESSENTI
[3]
Hypodermoclysis - a victim of historical prejudice [J].
Barua, P ;
Bhowmick, BK .
AGE AND AGEING, 2005, 34 (03) :215-217
[4]
NUTRITION BY HYPODERMOCLYSIS [J].
BERGER, EY .
JOURNAL OF THE AMERICAN GERIATRICS SOCIETY, 1984, 32 (03) :199-203
[5]
A recombinant human enzyme for enhanced interstitial transport of therapeutics [J].
Bookbinder, L. H. ;
Hofer, A. ;
Haller, M. F. ;
Zepeda, M. L. ;
G.-A., Keller ;
Lim, J. E. ;
Edgington, T. S. ;
Shepard, H. M. ;
Patton, J. S. ;
Frost, G. I. .
JOURNAL OF CONTROLLED RELEASE, 2006, 114 (02) :230-241
[6]
BOYD H W, 1951, Glasgow Med J, V32, P214
[7]
Bruera E, 1990, J Pain Symptom Manage, V5, P218, DOI 10.1016/0885-3924(90)90014-B
[8]
A randomized controlled trial of local injections of hyaluronidase versus placebo in cancer patients receiving subcutaneous hydration [J].
Bruera, E ;
Neumann, CM ;
Pituskin, E ;
Calder, K ;
Hanson, J .
ANNALS OF ONCOLOGY, 1999, 10 (10) :1255-1258
[9]
CLINICAL OBSERVATIONS ON THE USE OF HYALURONIDASE [J].
BURKET, LC ;
GYORGY, P .
ANNALS OF THE NEW YORK ACADEMY OF SCIENCES, 1950, 52 (07) :1171-1179
[10]
A COMPARISON OF INTRAVENOUS AND SUBCUTANEOUS HYDRATION IN ELDERLY ACUTE STROKE PATIENTS [J].
CHALLINER, YC ;
JARRETT, D ;
HAYWARD, MJ ;
ALJUBOURI, MA ;
JULIOUS, SA .
POSTGRADUATE MEDICAL JOURNAL, 1994, 70 (821) :195-197