Dehydration, Difficult Intravenous Access, Disaster Medicine
Conditions
Keywords
Disaster, Mass casualty incident, Prehospital, Rehydration, Intravascular access
Brief summary
Test whether Basic Life Support (BLS) providers can successfully place Enzymatically Augmented Subcutaneous Infusion (EASI) Access lines for subcutaneous infusion, and characterize intravascular absorption of EASI-administered (tracer-labelled) glucose (D5W).
Interventions
DRUGHuman recombinant hyaluronidase (HRH)
150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water)
PROCEDUREEnzymatically Augmented Subcutaneous Infusion (EASI) line placement
Subjects will under placement of an EASI line. This entails placement of a small (20-gauge) catheter in the upper back, in the subcutaneous space.
Sponsors
Baxter Healthcare Corporation
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects will be at least 18 years of age and have none of the following conditions: * pregnancy (negative urine pregnancy test to be performed before study participation), * diabetes, or coagulopathic (including taking any anticoagulants); * Subjects cannot be taking steroids or other immunosuppressants. * Because of the potential for reduced hyaluronidase effectiveness, the study excludes patients taking more than 80 mg daily aspirin, as well as any patients taking ACTH, antihistamines, or estrogen other than in oral contraceptive preparations. * Subjects will not be required to fast before the study, but will not allowed to eat or drink during the EASI infusion or the phlebotomy sampling time frame.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successfully Placed EASI Lines | 1 day | Ability of Basic Life Support (BLS) providers to place EASI access lines. The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed). |
| Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose | 1 day | Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pain During EASI Infusion | 1 day | Assessment during EASI placement & initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3. |
| Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up | 2 days | Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3. Presence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back). |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred in January 2009
Pre-assignment details
A total of 20 subjects were consented. The study day ran long, so 2 subjects who had consented (and had an initial intravenous {IV} access placed, but no EASI access placed) declined to have any of the study procedures performed since the 2-hour phlebotomy window would have kept them at the study site until the evening.
Participants by arm
| Arm | Count |
|---|---|
| EASI/HRH(Human Recombinant Hyaluronidase) Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | EASI/HRH(Human Recombinant Hyaluronidase) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age Continuous | 25 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 15 Participants |
Outcome results
Primary
Number of Participants With Successfully Placed EASI Lines
Ability of Basic Life Support (BLS) providers to place EASI access lines. The unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed).
Time frame: 1 day
Population: Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EASI/HRH(Human Recombinant Hyaluronidase) | Number of Participants With Successfully Placed EASI Lines | 18 Participants |
Primary
Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose
Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.
Time frame: 1 day
Population: Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EASI/HRH(Human Recombinant Hyaluronidase) | Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose | 18 Participants |
Secondary
Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up
Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3. Presence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back).
Time frame: 2 days
Population: Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EASI/HRH(Human Recombinant Hyaluronidase) | Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up | 0 Participants |
Comparison: This analysis reports the number of subjects (of 18 possible) who experienced pain, as assessed on next-day follow-up (24 hours after EASI infusion), at the a priori-defined level of at least 3 on a 10-point pain scale.97.5% CI: [0, 18.5]binomial exact confidence interval
Secondary
Number of Participants With Pain During EASI Infusion
Assessment during EASI placement & initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.
Time frame: 1 day
Population: Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EASI/HRH(Human Recombinant Hyaluronidase) | Number of Participants With Pain During EASI Infusion | 2 Participants |
Comparison: This analysis reports the number of subjects (of 18 possible) who experienced pain, during EASI placement or infusion, at the a priori-defined level of at least 3 on a 10-point pain scale.95% CI: [1.4, 34.7]95% binomial exact confidence interval