DehydrationPhase 4NCT01234883
Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis
A Phase 4 study testing multiple electrolyte solution and saline in people with Dehydration and Gastroenteritis, run by Baxter Healthcare Corporation at 9 sites in 2 countries.
Trial summary
The primary objective of this study is to compare the efficacy and safety of the use of a multiple electrolyte solution to the use of saline for the treatment of moderate to severe dehydration due to acute gastroenteritis (AGE) in children. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Dehydration, Gastroenteritis
- What is being tested?
- multiple electrolyte solution and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jun 2011to Feb 2013
- 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 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- AGE (etiology: viral or other) resulting in presentation to the ED deemed in need of IV rehydration. In the 24 hours prior to presentation, the subject experienced at least 3 episodes of diarrhea (loose and/or watery stools) and/or nonbilious vomiting.
- Moderate to severe dehydration (as assessed by Gorelick score13 ≥ 4
- ≥ 6 months to < 11 years of age.
- Healthy except for the underlying etiology of AGE.
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICFs and privacy language per national regulations (eg, Health Insurance Portability and Accountability Act [HIPAA], Personal Information Protection and Electronic Documents Act [PIPEDA]) were obtained from the parent/guardian prior to any study-related procedures.
Who cannot join
- AGE that did not require IV rehydration per the clinician.
- Gorelick score ≤ 3
- Bilious vomiting.
- Received > 20 mL/kg IV fluid bolus within the 4 hours prior to study enrollment (ie, Hour -4 to Hour 0).
- Diarrhea lasting > 7 days prior to presentation to the ED.
- Chronic vomiting disorder.
Show all 23Show fewer
- Grossly bloody diarrhea.
- Chronic diarrheal disorder.
- Known hyponatremia (sodium < 130 mmol/L [< 130 mEq/L]) within 72 hours prior to enrollment.
- Known hypernatremia (sodium > 155 mmol/L [> 155 mEq/L]) within 72 hours prior to enrollment.
- Known hypokalemia (potassium < 3.0 mmol/L [< 3.0 mEq/L]) within 72 hours prior to enrollment.
- Known hyperkalemia (potassium > 5.5 mmol/L [> 5.5 mEq/L]) within 72 hours prior to enrollment.
- The use of prohibited medications:
- Antacids within 24 hours prior to presentation to the ED and during the study.
- Anti-diarrhea medication within 24 hours prior to presentation to the ED and during the study.
- The systemic use of corticosteroids/corticotropins was prohibited within 72 hours of enrollment.
- Chronic health condition affecting the ability to tolerate fluids or those that result in electrolyte abnormalities (eg, chronic renal, cardiac, or pulmonary diagnoses), or abnormalities of sodium or potassium handling (eg, endocrine disorders, medications).
- Any reason for urgent or emergency hospital admission or ED stays of > 12 hours within 14 days preceding presentation to the ED.
- Any medical condition likely to interfere with the subject's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the subject's need for medical attention beyond that required for treatment of dehydration.
- Participation in a study of any investigational drug or device concomitantly or within 30 days prior to enrollment in this study, including previous enrollment in this study.
- Subject with a > 50% expected chance of dying within 6 months, in the Investigator's opinion.
- Known hypersensitivity to either of the investigational products.
- Other serious acute or active conditions that, in the Investigator's opinion, precluded participation in this study.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Emory University/Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Children's Hospital of Atlanta at Scottish Rite
Atlanta, Georgia, 30342
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Oregon Health and Science University
Portland, Oregon, 97239
Canada2 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: A Double-Blind, Randomized, Comparative Efficacy and Safety Trial of Intravenous Solutions for the Treatment of Moderate to Severe Dehydration in Children With Acute Gastroenteritis
The primary objective of this study is to compare the efficacy and safety of the use of a multiple electrolyte solution to the use of saline for the treatment of moderate to severe dehydration due to acute gastroenteritis (AGE) in children.
Read the detailed description
The primary objective of this study was to compare the efficacy and safety of the use of Plasma Lyte A to the use of NS for the treatment of moderate to severe dehydration and amelioration of metabolic acidosis due to AGE in children (≥ 6 months to < 11 years of age) by measuring serum bicarbonate levels.
- Conditions
- Dehydration, Gastroenteritis
- Being tested
- multiple electrolyte solution, saline
- Keywords
- dehydration, gastroenteritis
- Medical subject headings
- Dehydration, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple electrolyte solutionDrug
Also called Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP)
IV multiple electrolyte solution dosed as clinically indicated for rehydration
salineDrug
Also called 0.9% Normal Saline
IV solutions dosed as clinically indicated for rehydration
| Study group | Role | What they receive |
|---|---|---|
| multiple electrolyte solution | Experimental | Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling. Receives: Drug: multiple electrolyte solution |
| saline | Active comparator | Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling. Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)
The primary efficacy variable was venous serum bicarbonate (marker of metabolic acidosis) at Hour 4 (+/- 1 hour) from the start of the First IV Bolus.
Measured: Day 1 (4 Hours after start of IV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startJun 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Insufficient enrollment
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Drew Jones, MD, Study director, Baxter Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234883
- Sponsor's protocol ID
- CSPIVTUSA001
- Status last verified
- Mar 2018
- First submitted
- 3 Nov 2010
- Last updated
- 26 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Allen CH, Goldman RD, Bhatt S, Simon HK, Gorelick MH, Spandorfer PR, Spiro DM, Mace SE, Johnson DW, Higginbotham EA, Du H, Smyth BJ, Schermer CR, Goldstein SL. A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis. BMC Pediatr. 2016 Aug 2;16:117. doi: 10.1186/s12887-016-0652-4.
PubMed 27480410
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Comparative Efficacy and Safety Trial of Intravenous Solutions for the Treatment of Moderate to Severe Dehydration in Children With Acute Gastroenteritis
- ClinicalTrials.gov ID
- NCT01234883
- Acronym / sponsor ID
- CSPIVTUSA001
- Conditions
- Dehydration, Gastroenteritis
- Keywords
- dehydration, gastroenteritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Posted 7 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare the efficacy and safety of the use of a multiple electrolyte solution to the use of saline for the treatment of moderate to severe dehydration due to acute gastroenteritis (AGE) in children.
Detailed description
The primary objective of this study was to compare the efficacy and safety of the use of Plasma Lyte A to the use of NS for the treatment of moderate to severe dehydration and amelioration of metabolic acidosis due to AGE in children (≥ 6 months to < 11 years of age) by measuring serum bicarbonate levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiple electrolyte solution | Experimental | Drug: multiple electrolyte solutionSubjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling. |
| saline | Active comparator | Drug: salineSubjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling. |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- AGE (etiology: viral or other) resulting in presentation to the ED deemed in need of IV rehydration. In the 24 hours prior to presentation, the subject experienced at least 3 episodes of diarrhea (loose and/or watery stools) and/or nonbilious vomiting.
- Moderate to severe dehydration (as assessed by Gorelick score13 ≥ 4
- ≥ 6 months to < 11 years of age.
- Healthy except for the underlying etiology of AGE.
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICFs and privacy language per national regulations (eg, Health Insurance Portability and Accountability Act [HIPAA], Personal Information Protection and Electronic Documents Act [PIPEDA]) were obtained from the parent/guardian prior to any study-related procedures.
Key exclusion criteria (23 listed)
- AGE that did not require IV rehydration per the clinician.
- Gorelick score ≤ 3
- Bilious vomiting.
- Received > 20 mL/kg IV fluid bolus within the 4 hours prior to study enrollment (ie, Hour -4 to Hour 0).
- Diarrhea lasting > 7 days prior to presentation to the ED.
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 |
|---|---|---|
| multiple electrolyte solutionAlso: Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP)IV multiple electrolyte solution dosed as clinically indicated for rehydration | Drug | multiple electrolyte solution |
| salineAlso: 0.9% Normal SalineIV solutions dosed as clinically indicated for rehydration | Drug | saline |
Primary outcome
Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)
Time frame: Day 1 (4 Hours after start of IV)
The primary efficacy variable was venous serum bicarbonate (marker of metabolic acidosis) at Hour 4 (+/- 1 hour) from the start of the First IV Bolus.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27480410Allen CH, Goldman RD, Bhatt S, Simon HK, Gorelick MH, Spandorfer PR, Spiro DM, Mace SE, Johnson DW, Higginbotham EA, Du H, Smyth BJ, Schermer CR, Goldstein SL. A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis. BMC Pediatr. 2016 Aug 2;16:117. doi: 10.1186/s12887-016-0652-4.
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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.
Drew Jones, MD study director
Baxter Healthcare
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing multiple electrolyte solution and saline in people with Dehydration and Gastroenteritis, run by Baxter Healthcare Corporation at 9 sites in 2 countries.
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 5 inclusion and 23 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 26 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 9 sites in United States, 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?
Yes. Results are posted in the registry (first posted 7 Apr 2014). 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?
Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV) (time frame: Day 1 (4 Hours after start of IV)). 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 NCT01234883, which also lists 1 linked publication.
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 26 Apr 2018.