Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial

NCT00734214 | Completed Phase 3 Results

• 1 other identifier: 07-265
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

Children who are undergoing surgery need intravenous fluids to prevent dehydration and maintain their electrolyte balance. The current standard of care in these children is to use a fluid which is low in sodium (hypotonic fluid). The safety of this practice has never been tested. There is ongoing concern from the medical community that this type of fluid increases the child's risk of developing low sodium levels, and hence may not be safe for all children. Low sodium can lead to significant complications such as seizures, coma and even death, risks of which are often underestimated and not anticipated by their caregivers. Experts in the field suggest that giving a solution with a similar sodium content to that of blood (isotonic fluid) reduces the risk of these problems in these children. This study will compare these two types of intravenous fluids (hypotonic versus isotonic), in a blinded fashion (i.e. neither the patient nor caregivers or investigators will be aware which type of fluid the patient is receiving), in children following surgery. The investigators goal is to see which type of fluid is safer, and leads to more stable sodium levels. This would in turn lead to a lower risk of complications as described above. This is the first time such a study is preformed in pediatrics. There are unnecessary number of complications and potential deaths from this disorder, and hence the safety of everyday fluid practice in children needs to be scientifically tested. The results of this study will enable the investigators to propose scientifically based guidelines on how to minimize risks associated with intravenous infusions in children.

Conditions

Hyponatremia; Hypernatremia

Keywords

Parenteral Fluids; Isotonic; Hypotonic; Pediatric; Fluid overload

Outcome Measures

Primary Outcomes (2)

• Hospital Acquired Acute Plasma Sodium Derangements (Hypo- or Hypernatremia)

  During the treatment and follow-up period.

• Hyponatremia

  Plasma sodium less than 135 mmol/L

  during the study intervention

Secondary Outcomes (1)

• Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes.

  During the treatment and follow-up period

Study Arms (2)

0.9% NaCl

EXPERIMENTAL

Drug: 0.9% NaCl

0.45% NaCl

ACTIVE COMPARATOR

Drug: 0.45%NaCl

Interventions

0.9% NaCl DRUG

Intravenous Fluid Isotonic Parenteral Fluid

Also known as: Isotonic saline

0.9% NaCl

0.45%NaCl DRUG

Intravenous Fluid Hypotonic Parenteral Fluid

Also known as: Hypotonic saline

0.45% NaCl

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients, 6 months corrected age -16 years, undergoing surgery.
• Within 6 hours of the immediate post-operative period.
• Post-operative stay anticipated to be more than 24 hours.
• Primary route of fluid administration is anticipated to be intravenous, in the first 24 hours following surgery.
• Informed consent of parent/guardian.
• Consent to participate from surgeon.

You may not qualify if:

• Patients under 6 months of age
• Patients equal to or over 17 years of age
• Patients with hemodynamic instability , defined as a requirement for continuous vasoactive infusion (e.g. epinephrine, dopamine, norepinephrine, phenylephrine, milrinone, or Dobutamine) to maintain blood pressure at the end of surgery.
• Patients admitted into the "short stay" post-operative unit
• Patients in whom either hypotonic or isotonic solutions may be contraindicated/necessary: i.e. specific neurosurgical patients (ie those at risk of increased ICP, e.g. requiring actual brain surgery, ICP monitor or external ventricular drain insertion), patients with diabetic ketoacidosis, acute (≤ 7 days) burns, pre-existing CHF, liver failure or cirrhosis, renal failure.
• Patients with known pre-existing risk of PNa derangements: DI or SIADH
• Chronic diuretic use - defined as use of any oral or intravenous diuretics for ≥ 7 days.
• Known, uncorrected PNa derangement (PNa \< 134 or \> 146 mmol/L), identified peri-operatively (i.e. within 12 hours of surgery or during surgery).
• Prior enrolment in this study
• Patients or their guardians objecting to give consent.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

• Choong K, Arora S, Cheng J, Farrokhyar F, Reddy D, Thabane L, Walton JM. Hypotonic versus isotonic maintenance fluids after surgery for children: a randomized controlled trial. Pediatrics. 2011 Nov;128(5):857-66. doi: 10.1542/peds.2011-0415. Epub 2011 Oct 17.

  PMID: 22007013 DERIVED

MeSH Terms

Conditions

Hyponatremia; Hypernatremia; Edema

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Karen Choong
• Organization: McMaster University

choongk@mcmaster.ca

905-5212100

Study Officials

• Karen Choong, MB, BCh, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 29, 2015
• Results First Posted: June 13, 2012

Record last verified: 2015-04

Locations

CA (1)