GastroenteritisPhase 4NCT00392145
Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis
A Phase 4 study testing Standard IV rehydration and Rapid intravenous rehydration (RIVR) in people with Gastroenteritis and Dehydration, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This study will look at children with dehydration secondary to gastroenteritis requiring IV rehydration and determine whether the proportion rehydrated after two hours is greater in the children who receive rapid intravenous rehydration (RIVR) or in the children who receive standard IV rehydration. Read more about this study
- Who is it for?
- Ages 90 days to 18 years
- Conditions the study is for
- Gastroenteritis, Dehydration
- What is being tested?
- Standard IV rehydration and Rapid intravenous rehydration (RIVR)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 90 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Acute gastroenteritis as determined by the supervising physician.
- Age greater than 90 days
- Dehydrated and unable to consume sufficient oral fluids to overcome their dehydration state
Who cannot join
- Weight less than 5 kg or greater than 33 kg
- Underlying disease which may limit the amount of IV fluids given,including but not limited to: hypoalbuminemic states, renal insufficiency, heart disease requiring pharmacotherapy or lesions that may predispose to congestive heart failure, hypertension, chronic lung disease (excluding asthma), diabetes mellitus, severe anemia, and chronic inflammatory disease
- Clinical suspicion by the attending physician of myocarditis or previously undiagnosed cardiac or renal disease.
- History of abdominal surgery or concern regarding an acute surgical abdomen
- Significant head, chest or abdominal trauma within the preceding 7 days
- Bilious or bloody vomitus
Show all 10Show fewer
- Evidence of hemodynamic compromise (BP < 80 + 2 * age (yrs)) requiring > 20 mL/kg 0.9% normal saline to be administered in the 1st hour
- Bedside glucose < 2.8 mmol/L (see Section 8.3)
- Unable to provide a telephone number or unavailable for follow-up
- Previously enrolled in this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis: A Randomized Controlled Trial
This study will look at children with dehydration secondary to gastroenteritis requiring IV rehydration and determine whether the proportion rehydrated after two hours is greater in the children who receive rapid intravenous rehydration (RIVR) or in the children who receive standard IV rehydration.
Read the detailed description
Despite a movement toward increased use of enteral rehydration, many children still receive prolonged IV rehydration in the emergency department (ED). These children commonly receive a single IV bolus of normal saline followed by the administration of a hypotonic solution at a maintenance rate.
The mean time spent in the ED by children receiving IV rehydration is significantly longer than the mean time required to treat all other conditions. ED overcrowding has been associated with poor outcomes, prolonged pain and suffering, and dissatisfaction. One of the solutions proposed in the American Academy of Pediatrics Policy Statement on ED overcrowding is that hospitals should strive to improve the efficiency of the care provided. One small step in this direction may be to improve our management of gastroenteritis and dehydration.
- Conditions
- Gastroenteritis, Dehydration
- Being tested
- Standard IV rehydration, Rapid intravenous rehydration (RIVR)
- Keywords
- Pediatrics, Gastroenteritis, Dehydration, IV Rehydration
- Medical subject headings
- Gastroenteritis, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard IV rehydrationDrug
A 20 mL/kg 0.9% normal saline bolus (maximum 999 mL) will be administered over 1 hour. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr).
Rapid intravenous rehydration (RIVR)Drug
A 60 mL/kg 0.9% normal saline bolus (maximum 999 mL) over 1 hour will be administered. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Standard IV rehydration |
| 2 | Experimental | Not described Receives: Drug: Rapid intravenous rehydration (RIVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehydration criteria defined by: dehydration score ≤ 1, normal capillary refill time, normal skin turgor, normal respiratory rate
Measured: 2 hours following the initiation of IV rehydration
Secondary outcomes (5)
Hospitalization
Measured: 72 hours
Ability to tolerate oral rehydration
Measured: Measured per 2 hour time period after consuming 5 mL/kg of liquid
Repeat ED visit
Measured: 72 hours
Time (in minutes) from initiation of IV rehydration until disposition determination
Measured: Determined by outcome
Attending physician discharge comfort level
Measured: Two and four hours following initiation of IV rehydration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Stephen Freedman, The Hospital for Sick Children
- Investigators
- Stephen B Freedman, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392145
- Sponsor's protocol ID
- 1000008579
- Status last verified
- Apr 2018
- First submitted
- 27 Jun 2006
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Freedman SB, DeGroot JM, Parkin PC. Successful discharge of children with gastroenteritis requiring intravenous rehydration. J Emerg Med. 2014 Jan;46(1):9-20. doi: 10.1016/j.jemermed.2013.04.044. Epub 2013 Aug 30.
PubMed 23993936Freedman SB, Parkin PC, Willan AR, Schuh S. Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial. BMJ. 2011 Nov 17;343:d6976. doi: 10.1136/bmj.d6976.
PubMed 22094316
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00392145
- Acronym / sponsor ID
- 1000008579
- Conditions
- Gastroenteritis, Dehydration
- Keywords
- Pediatrics, Gastroenteritis, Dehydration, IV Rehydration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Nov 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 25 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at children with dehydration secondary to gastroenteritis requiring IV rehydration and determine whether the proportion rehydrated after two hours is greater in the children who receive rapid intravenous rehydration (RIVR) or in the children who receive standard IV rehydration.
Detailed description
Despite a movement toward increased use of enteral rehydration, many children still receive prolonged IV rehydration in the emergency department (ED). These children commonly receive a single IV bolus of normal saline followed by the administration of a hypotonic solution at a maintenance rate.
The mean time spent in the ED by children receiving IV rehydration is significantly longer than the mean time required to treat all other conditions. ED overcrowding has been associated with poor outcomes, prolonged pain and suffering, and dissatisfaction. One of the solutions proposed in the American Academy of Pediatrics Policy Statement on ED overcrowding is that hospitals should strive to improve the efficiency of the care provided. One small step in this direction may be to improve our management of gastroenteritis and dehydration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Standard IV rehydration |
| 2 | Experimental | Drug: Rapid intravenous rehydration (RIVR) |
Who may qualify
- Ages
- 90 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Acute gastroenteritis as determined by the supervising physician.
- Age greater than 90 days
- Dehydrated and unable to consume sufficient oral fluids to overcome their dehydration state
Key exclusion criteria (10 listed)
- Weight less than 5 kg or greater than 33 kg
- Underlying disease which may limit the amount of IV fluids given,including but not limited to: hypoalbuminemic states, renal insufficiency, heart disease requiring pharmacotherapy or lesions that may predispose to congestive heart failure, hypertension, chronic lung disease (excluding asthma), diabetes mellitus, severe anemia, and chronic inflammatory disease
- Clinical suspicion by the attending physician of myocarditis or previously undiagnosed cardiac or renal disease.
- History of abdominal surgery or concern regarding an acute surgical abdomen
- Significant head, chest or abdominal trauma within the preceding 7 days
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 |
|---|---|---|
| Standard IV rehydrationA 20 mL/kg 0.9% normal saline bolus (maximum 999 mL) will be administered over 1 hour. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr). | Drug | 1 |
| Rapid intravenous rehydration (RIVR)A 60 mL/kg 0.9% normal saline bolus (maximum 999 mL) over 1 hour will be administered. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr). | Drug | 2 |
Primary outcome
Rehydration criteria defined by: dehydration score ≤ 1, normal capillary refill time, normal skin turgor, normal respiratory rate
Time frame: 2 hours following the initiation of IV rehydration
5 secondary outcomes
Hospitalization
Time frame: 72 hours
Ability to tolerate oral rehydration
Time frame: Measured per 2 hour time period after consuming 5 mL/kg of liquid
Repeat ED visit
Time frame: 72 hours
Time (in minutes) from initiation of IV rehydration until disposition determination
Time frame: Determined by outcome
Attending physician discharge comfort level
Time frame: Two and four hours following initiation of IV rehydration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 23993936Freedman SB, DeGroot JM, Parkin PC. Successful discharge of children with gastroenteritis requiring intravenous rehydration. J Emerg Med. 2014 Jan;46(1):9-20. doi: 10.1016/j.jemermed.2013.04.044. Epub 2013 Aug 30.
- Derived from this study: PubMed 22094316Freedman SB, Parkin PC, Willan AR, Schuh S. Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial. BMJ. 2011 Nov 17;343:d6976. doi: 10.1136/bmj.d6976.
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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.
Stephen B Freedman, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard IV rehydration and Rapid intravenous rehydration (RIVR) in people with Gastroenteritis and Dehydration, run by The Hospital for Sick Children at 1 site in Canada.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 17 Apr 2018. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rehydration criteria defined by: dehydration score ≤ 1, normal capillary refill time, normal skin turgor, normal respiratory rate (time frame: 2 hours following the initiation of IV rehydration). 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 NCT00392145, which also lists 2 linked publications.
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 17 Apr 2018.