Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

NCT01234883 | Terminated Phase 4 Results

• 1 other identifier: CSPIVTUSA001
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Dehydration; Gastroenteritis

Keywords

dehydration; gastroenteritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 (4 Hours after start of IV)

Study Arms (2)

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.

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.

Drug: saline

Interventions

multiple electrolyte solution DRUG

IV multiple electrolyte solution dosed as clinically indicated for rehydration

Also known as: Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP)

multiple electrolyte solution

saline DRUG

IV solutions dosed as clinically indicated for rehydration

Also known as: 0.9% Normal Saline

saline

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (9)

Emory University/Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Children's Hospital of Atlanta at Scottish Rite

Atlanta, Georgia, 30342, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (1)

• 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.

  PMID: 27480410 DERIVED

MeSH Terms

Conditions

Dehydration; Gastroenteritis

Interventions

Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Early termination of study due to low enrollment.

Results Point of Contact

• Title: Drew Jones, M.D.
• Organization: Baxter Healthcare

Drew_Jones@baxter.com

224-270-2659

Study Officials

• Drew Jones, MD

  Baxter Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 4, 2010
• Study Start: June 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 26, 2018
• Results First Posted: April 7, 2014

Record last verified: 2018-03

Locations

CA (2); US (7)