The INcreased Flow Utilizing Subcutaneously-Enabled Normal Saline and Lactated Ringer's (INFUSE-NSLR) Study: A Phase IV, Double-Blind, Randomized Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex) in Volunteer Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS)
研究概览
简要总结
Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units.
In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR) solution. Each subject will receive 500 milliliters (mL) of solution, consisting of NS in one thigh and LR in the other thigh. Immediately prior to the infusions, each thigh will have 150 units of hylenex.
In Stage 2, the comparison will be NS solution and buffered NS solution.
详细描述
This Phase IV, randomized, double-blinded study in volunteer subjects to evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units. The study will be conducted in two sequential stages.
In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.
Tolerability will be assessed based on the subject's self-assessment of discomfort on a visual analog scale (VAS). Safety will be assessed by physical examination targeted at infusion sites, vital signs, and adverse events. The amount of fluid infused will be assessed by weighing the infusion bag, fluid and tubing at designated time points, and allowing the determination of flow rate.
Stage 2 will be conducted only if the observed Stage 1 VAS mean maximum pain score is at least 25 mm higher for one solution compared to the other. Stage 2 will evaluate the tolerability, safety, and flow rates of subcutaneously infused NS solution and buffered NS solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18 to 60 years of age.
- •Intact normal skin without in the areas intended for infusion.
- •No fluid intake for 12 hours prior to the start of the study infusion.
- •Vital signs (Blood Pressure (BP), Heart Rate (HR), Respiratory Rate (RR)) within normal range.
- •Metabolic panel within normal range.
- •A negative urine or serum pregnancy test.
- •Signed, written Institutional Review Board (IRB)-approved informed consent.
排除标准
- •Lower extremity edema.
- •Lower extremity pathology that could interfere with study outcome.
- •Rales on lung auscultation.
- •History of cardiovascular disease.
- •Allergy to hyaluronidase.
- •Allergy to bee or vespid venom.
- •Pregnancy or breast-feeding woman.
- •Use of any investigational drug or device within 30 days of enrollment.
研究组 & 干预措施
NS Infusion Group
Normal Saline (NS) and Hylenex
干预措施: recombinant human hyaluronidase (Drug)
LR Infusion Group
Lactated Ringer's (LR) and Hylenex
干预措施: recombinant human hyaluronidase (Drug)
结局指标
主要结局
The Participant's Assessment of Discomfort at the Infusion Site on a Visual Analog Scale (VAS)
时间窗: Approximate times which ranged from zero minutes at baseline to maximal post-infusion of 240 minutes on Day 1
Participant's self-assessment of discomfort at the infusion site by means of a validated VAS with a range of 0 millimeters (mm) (no discomfort) to 100 mm (worst possible discomfort), for the comparison of subcutaneous (SC) infusion of normal saline (NS) versus Lactated Ringer's (LR), each following an SC slow-push injection of 150 Units (U) Hylenex.
次要结局
- Average Infusion Flow Rate (Milliliters Per Hour [mL/hr]) Derived From the Time to Infuse up to 500 mL of Solution(During infusion on Day 1)
- Number of Participants Assessed for Safety Measures(Baseline, Mid-Infusion Right and Left, Post-Infusion Right and Left, Discharge Right and Left (up to approximately 8 days))
- Percent Change From Baseline Thigh Circumference to Maximum Post-Baseline Thigh Circumference at Infusion Sites(Before the infusion, during the infusion, after the infusion, and discharge (Day 1))
- Time From the Beginning of Infusion Until the Thigh Circumference Returns to Within 5% of Baseline Circumference(Before the infusion (Baseline) until discharge (Day 1))
- Number of Participant's With the Indicated Global Preference for Infusion (Left Versus Right Thigh)(End of infusion (Day 1))