Phase 4
N=148
Subcutaneous Rehydration Compared to Intravenous Rehydration
Dehydration
Bottom Line
View on ClinicalTrials.gov: NCT00773175 ↗Enrolled (actual)
148
Serious AEs
4.7%
Results posted
Nov 2018
Primary outcome: Primary: Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants — 365.0; 455.8; 334.3; 299.6 milliliters — p=0.5064
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- recombinant human hyaluronidase (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Halozyme Therapeutics
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants |
365.0; 455.8; 334.3; 299.6 | 0.5064 |
| PRIMARY Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants |
365.0; 579.4; 334.3; 380.8 | 0.8915 |
| PRIMARY Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants |
388.3; 315.3 | — |
| SECONDARY Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants |
365.4; 455.8; 334.7; 299.6 | 0.5035 |
| SECONDARY Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants Achieving > 200 mL |
— | — |
| SECONDARY Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants Achieving > 200 mL |
— | — |
| SECONDARY Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Rescued Participants Achieving > 200 mL |
— | — |
| SECONDARY Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants |
183.8; 166.1; 186.4; 179.6 | — |
| SECONDARY Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants |
183.8; 211.1; 186.4; 228.3 | — |
| SECONDARY Mean Flow Rate, Delivered Per Unit Time, for All Rescued Participants |
139.1; 149.8 | — |
| SECONDARY Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants |
15.4; 12.3; 15.6; 13.3 | — |
| SECONDARY Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants |
15.4; 15.7; 15.6; 17.1 | — |
| SECONDARY Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Rescued Participants |
14.4; 15.4 | — |
| SECONDARY Number of Participants Achieving a Maximum Flow Rate of > 2 Milliliters Per Minute (mL/Min), as an Indication of Successful Hydration |
68; 57 | — |
| SECONDARY Number of Participants Administered at Least 200 Milliliter (mL) Total Volume at a Single Infusion Site, From the Start to the Cessation of Fluid Administration |
18; 27 | — |
| SECONDARY Number of Participants With the Indicated Type of Adverse Events |
73; 68; 73; 63; 72; 32 | — |
| SECONDARY Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Mean Change From Baseline in Heart Rate |
-6.9; -4.8; -11.3 | — |
| SECONDARY Mean Change From Baseline in Respiratory Rate |
-4.8; -1.3; -2.6 | — |
| SECONDARY Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure |
3.2; 1.1; -4.0; -0.2; 0.7; -2.9 | — |
| SECONDARY Mean Change From Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale Score |
-4.4; -5.2; -3.8 | — |
| SECONDARY Number of Participants With the Indicated Type of Fluid Administered |
28; 9; 6; 44; 49; 9 | — |
| SECONDARY Infusion Duration During the Initial Infusion |
1.0; 0.8 | — |
| SECONDARY Change From Baseline in Hydration Status According to the Gorelick Assessment at the End of Fluid Infusion |
-2.6; -2.2 | 0.0658 |
| SECONDARY Percent Change From Baseline in Body Weight |
2.9; 3.8 | 0.6208 |
| SECONDARY Number of Participants With the Indicated Type of Rescue Route Therapy Administered |
0; 15; 0; 0 | — |
| SECONDARY Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire |
68; 57; 4; 13; 1; 5 | 0.0685 |
| SECONDARY Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? |
3; 1; 58; 41; 11; 0 | 0.0033 sig |
| SECONDARY Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire |
70; 59; 3; 8; 0; 8 | 0.2012 |
| SECONDARY Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration |
72; 59; 15; 1; 0; 0 | — |
| SECONDARY Number of Participants Experiencing Reductions in Flow Rate |
43; 39 | — |
| SECONDARY Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training |
28; 4; 1; 35; 48; 10 | — |
| SECONDARY Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement |
20; 1; 1; 36; 34; 5 | — |
| SECONDARY Time From the Start of Infusion to the Time of Emergency Department (ED) Discharge |
4.0; 3.1; 4.7 | — |
| SECONDARY Time From Randomization to the First Drop of Fluid Infusion |
37; 42.5 | 0.0247 sig |
| SECONDARY Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration |
69; 54; 4; 13; 0; 7 | 0.0007 sig |
| SECONDARY Number of Participants for Which the Indicated Type of Infusion Device Was Used |
63; 57; 15; 10; 1; 0 | — |
| SECONDARY Number of Participants for Which the Indicated Gauge for Infusion Device Was Used |
2; 0; 0; 28; 22; 5 | — |
| SECONDARY Number of Participants Discharged From the ED to Home or the Hospital |
60; 64; 13; 10 | — |
| SECONDARY Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge |
2; 2; 7; 8 | — |
Summary
Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.
Eligibility Criteria
Inclusion Criteria
- Children of either gender from one month to ≤10 years of age.
- Patients with mild or moderate dehydration
- Healthy child except for the underlying etiology for dehydration
- Pre-dehydration body weight ≥ 5th percentile for age
- Parents or legal guardian(s) available to provide informed consent.
Exclusion Criteria
- Severe dehydration
- Shock or life-threatening situation (life expectancy 155 mEq/L).
- Known hypokalemia (< 3.0 mEq/L).
- 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 treatment of dehydration.
- Participation in an investigational drug or device study within 30 days prior to enrollment in this study.
Data sourced from ClinicalTrials.gov (NCT00773175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.