DehydrationPhase 4INFUSE-AT1ANCT01116102

Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A)

A Phase 4 study testing Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution in people with Dehydration, run by Baxter Healthcare Corporation at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose is to characterize the in-line pressure profiles associated with several infusion technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded by recombinant human hyaluronidase (hylenex). Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Dehydration
What is being tested?: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: May 2010to Jun 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female, aged 18 to 60 years, inclusive.
Body mass index 19.0 to 35.0 kg/m2
Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on the upper back in the area intended for infusion
Free from any clinically significant abnormality on the basis of medical/medication history or physical examination
Vital signs and clinical laboratory parameters within normal range or, if outside normal range, deemed not clinically significant
Negative urine drug and alcohol screens.

Who cannot join

Upper back pathology that could interfere with study outcome.
History of congestive heart failure, known coronary heart disease, active or recent pulmonary disease, or renal insufficiency.
Rales on lung auscultation.
Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
Treatment with furosemide, benzodiazepines, or phenytoin.
Pregnancy or breastfeeding.
Exposure to any experimental drug within 30 days prior to study admission, or previous participation in this study.
Any other reason which, in the investigator's opinion, would prevent the safe participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Kendle International, Inc. Drug Study Unit
Morgantown, West Virginia, 26505

Other trials in United States

About this study

Official title: The INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique 1A Study (INFUSE-AT 1A): A Randomized, Parallel Group Study to Evaluate the In-line Pressure, Flow Rate, Safety and Tolerability of Hylenex-facilitated Subcutaneous Fluid Administration In Healthy Volunteers Using Various Subcutaneous Infusion Techniques

Conditions: Dehydration
Being tested: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
Keywords: dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20
Medical subject headings: Dehydration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solutionDrug
Also called rHuPH20, LR solution
Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution

Study groups in NCT01116102
Study group	Role	What they receive
24 ga catheter, dose flush, single-step rate scheme	Experimental	Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion. Receives: Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
24 ga catheter, no dose flush, single-step rate scheme	Experimental	Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion. Receives: Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
24 ga catheter, dose flush, up-titrated rate scheme	Experimental	Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion. Receives: Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
24 ga catheter, no dose flush, up-titrated rate scheme	Experimental	Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion. Receives: Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
25 ga needle, dose flush, single-step rate scheme	Experimental	Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion. Receives: Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
25 ga needle, no dose flush, single-step rate scheme	Experimental	Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion. Receives: Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
25 ga needle, dose flush, up-titrated rate scheme	Experimental	Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion. Receives: Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution
25 ga needle, no dose flush, up-titrated rate scheme	Experimental	Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion. Receives: Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Measured In-line Fluid Pressure
Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion
Measured: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion

Secondary outcomes (3)

Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement
Measured: end of catheter/needle placement
Cumulative Fluid Volume Delivered
Measured: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion
Technical Challenges Encountered During Fluid Infusion
Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems
Measured: at any occurence of a defined challenge or at end of infusion if no challenges occurred

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Jun 2010

First posted4 May 2010 (estimated)
Study startMay 2010
Primary completionMay 2010
Study completionJun 2010

Why it stopped: Strategic business decision (not related to safety or efficacy concerns)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DehydrationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01116102
Sponsor's protocol ID: 1838-009
Acronym: INFUSE-AT1A
Status last verified: Oct 2011
First submitted: 30 Apr 2010
Last updated: 24 Oct 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
Recruiting
Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
Obesity & Overweight, Type 2 Diabetes
Recruiting
Hydration & Female Life Stages
Dehydration, Menstruation

All Dehydration trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique 1A Study (INFUSE-AT 1A): A Randomized, Parallel Group Study to Evaluate the In-line Pressure, Flow Rate, Safety and Tolerability of Hylenex-facilitated Subcutaneous Fluid Administration In Healthy Volunteers Using Various Subcutaneous Infusion Techniques
ClinicalTrials.gov ID: NCT01116102
Acronym / sponsor ID: INFUSE-AT1A / 1838-009
Conditions: Dehydration
Keywords: dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Strategic business decision (not related to safety or efficacy concerns)
Enrolment: 20 participants (actual)
Lead sponsor: Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
Collaborators: Halozyme Therapeutics
Study start: May 2010
Primary completion: May 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 4 May 2010 (estimated)
Results: Posted 18 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
24 ga catheter, dose flush, single-step rate scheme	Experimental	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solutionSingle 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.
24 ga catheter, no dose flush, single-step rate scheme	Experimental	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solutionSingle 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.
24 ga catheter, dose flush, up-titrated rate scheme	Experimental	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solutionSingle 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.
24 ga catheter, no dose flush, up-titrated rate scheme	Experimental	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solutionSingle 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.
25 ga needle, dose flush, single-step rate scheme	Experimental	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solutionSingle 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.
25 ga needle, no dose flush, single-step rate scheme	Experimental	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solutionSingle 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.
25 ga needle, dose flush, up-titrated rate scheme	Experimental	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solutionSingle 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.
25 ga needle, no dose flush, up-titrated rate scheme	Experimental	Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solutionSingle 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Male or female, aged 18 to 60 years, inclusive.
Body mass index 19.0 to 35.0 kg/m2
Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on the upper back in the area intended for infusion
Free from any clinically significant abnormality on the basis of medical/medication history or physical examination
Vital signs and clinical laboratory parameters within normal range or, if outside normal range, deemed not clinically significant

Key exclusion criteria (8 listed)

Upper back pathology that could interfere with study outcome.
History of congestive heart failure, known coronary heart disease, active or recent pulmonary disease, or renal insufficiency.
Rales on lung auscultation.
Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
Treatment with furosemide, benzodiazepines, or phenytoin.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solutionAlso: rHuPH20, LR solutionSubcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution	Drug	24 ga catheter, dose flush, single-step rate scheme, 24 ga catheter, dose flush, up-titrated rate scheme, 24 ga catheter, no dose flush, single-step rate scheme, 24 ga catheter, no dose flush, up-titrated rate scheme, 25 ga needle, dose flush, single-step rate scheme, 25 ga needle, dose flush, up-titrated rate scheme, 25 ga needle, no dose flush, single-step rate scheme, 25 ga needle, no dose flush, up-titrated rate scheme

Primary outcome

Maximum Measured In-line Fluid Pressure
Time frame: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion
Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion

3 secondary outcomes

Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement
Time frame: end of catheter/needle placement
Cumulative Fluid Volume Delivered
Time frame: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion
Technical Challenges Encountered During Fluid Infusion
Time frame: at any occurence of a defined challenge or at end of infusion if no challenges occurred

Results and safety

Results posted to the registry on 18 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
24 ga Catheter, Dose Flush, Single-step Rate Scheme	2	2
24 ga Catheter, No Dose Flush, Single-step Rate Scheme	3	3
24 ga Catheter, Dose Flush, Up-titrated Rate Scheme	3	3
24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme	3	3
25 ga Needle, Dose Flush, Single-step Rate Scheme	2	2
25 ga Needle, No Dose Flush, Single-step Rate Scheme	2	2
25 ga Needle, Dose Flush, Up-titrated Rate Scheme	2	2
25 ga Needle, No Dose Flush, Up-titrated Rate Scheme	3	3

Primary outcome: Maximum Measured In-line Fluid Pressure

Time frame: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion. Mean (Full Range). Unit: psi

Measure	24 ga Catheter, Dose Flush, Single-step Rate Scheme n = 2	24 ga Catheter, No Dose Flush, Single-step Rate Scheme n = 3	24 ga Catheter, Dose Flush, Up-titrated Rate Scheme n = 2	24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme n = 3	25 ga Needle, Dose Flush, Single-step Rate Scheme n = 2	25 ga Needle, No Dose Flush, Single-step Rate Scheme n = 1	25 ga Needle, Dose Flush, Up-titrated Rate Scheme n = 2	25 ga Needle, No Dose Flush, Up-titrated Rate Scheme n = 3
1 min	6.9 (2.6 to 11.1)	3.0 (2.6 to 3.5)	6.8 (3.1 to 10.6)	5.0 (1.5 to 11.7)	3.8 (3.7 to 3.8)	2.8 (2.8 to 2.8)	1.1 (1.0 to 1.2)	3.0 (1.5 to 5.1)
2 min	6.8 (2.8 to 10.8)	2.4 (2.1 to 2.7)	7.8 (3.3 to 12.3)	5.9 (1.0 to 14.2)	4.1 (3.8 to 4.4)	3.1 (3.1 to 3.1)	1.1 (0.9 to 1.4)	2.4 (1.1 to 4.7)
3 min	6.7 (2.8 to 10.6)	2.1 (1.9 to 2.5)	7.4 (3.5 to 11.2)	6.1 (1.3 to 14.9)	4.2 (4.1 to 4.4)	3.2 (3.2 to 3.2)	1.2 (1.1 to 1.3)	2.5 (1.0 to 4.9)
4 min	6.6 (2.8 to 10.4)	2.1 (1.8 to 2.5)	7.3 (3.7 to 11.0)	6.0 (1.0 to 15.9)	4.3 (4.3 to 4.3)	3.2 (3.2 to 3.2)	1.0 (1.0 to 1.1)	2.8 (1.6 to 4.7)
5 min	6.1 (2.7 to 9.5)	2.6 (1.8 to 4.1)	9.1 (7.7 to 10.6)	5.7 (1.0 to 15.1)	4.4 (4.3 to 4.4)	3.2 (3.2 to 3.2)	1.1 (1.1 to 1.1)	2.5 (1.1 to 4.9)
6 min	6.2 (2.8 to 9.6)	3.3 (1.8 to 6.0)	8.0 (4.9 to 11.1)	7.1 (1.4 to 18.4)	4.1 (4.0 to 4.2)	3.2 (3.2 to 3.2)	2.2 (2.1 to 2.2)	2.4 (2.2 to 2.5)
7 min	6.2 (2.8 to 9.7)	3.2 (1.9 to 5.7)	8.8 (3.4 to 14.1)	7.1 (1.6 to 17.8)	4.1 (4.1 to 4.2)	3.2 (3.2 to 3.2)	2.1 (2.1 to 2.2)	3.8 (2.2 to 6.9)
8 min	6.4 (2.8 to 10.1)	3.6 (2.0 to 5.9)	9.0 (3.7 to 14.4)	7.3 (2.8 to 16.1)	4.2 (4.1 to 4.3)	3.2 (3.2 to 3.2)	2.1 (2.1 to 2.2)	4.6 (2.1 to 7.6)

Population analysed: Per protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
24 ga Catheter, Dose Flush, Single-step Rate Scheme	0 of 2 (0%)	2 of 2 (100%)	Not reported
24 ga Catheter, No Dose Flush, Single-step Rate Scheme	0 of 3 (0%)	3 of 3 (100%)	Not reported
24 ga Catheter, Dose Flush, Up-titrated Rate Scheme	0 of 3 (0%)	3 of 3 (100%)	Not reported
24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme	0 of 3 (0%)	3 of 3 (100%)	Not reported
25 ga Needle, Dose Flush, Single-step Rate Scheme	0 of 2 (0%)	2 of 2 (100%)	Not reported
25 ga Needle, No Dose Flush, Single-step Rate Scheme	0 of 2 (0%)	2 of 2 (100%)	Not reported
25 ga Needle, Dose Flush, Up-titrated Rate Scheme	0 of 2 (0%)	2 of 2 (100%)	Not reported
25 ga Needle, No Dose Flush, Up-titrated Rate Scheme	0 of 3 (0%)	3 of 3 (100%)	Not reported

Limitations and caveats (from the sponsor): Due to small numbers of subjects in each treatment arm, no conclusions can be drawn on the influence of any of the individual potential pressure-affecting factors or the combinations of these factors on in-line fluid pressure.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dehydration

Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Enrolling by invitation
Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Not yet recruitingPhase 2
Ondansetron to Prevent Oral Rehydration Failure in Children With Cholera
Cholera (Disorder)
Recruiting
Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
Obesity & Overweight, Type 2 Diabetes
Recruiting
Hydration & Female Life Stages
Dehydration, Menstruation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

George Harb, MD, MPH study director

Baxter Healthcare Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Measured In-line Fluid Pressure (time frame: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01116102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2011.