Hypotonic Versus Isotonic Parenteral (HIP) Fluid Trial - Full Text View

Sponsored by:	Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00734214

Purpose

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 enablethe investigators to propose scientifically based guidelines on how to minimize risks associated with intravenous infusions in children.

Condition	Intervention	Phase
Hyponatremia Hypernatremia	Drug: 0.9% NaCl Drug: 0.45%NaCl	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Official Title:	Hypotonic Versus Isotonic Parenteral Fluids in Children - a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Caregivers

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

Hospital acquired acute Plasma Sodium derangements (hypo- or hypernatremia) [ Time Frame: During the treatment and follow-up period. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adjudicated morbidity attributed to acute Plasma sodium changes. [ Time Frame: During the treatment and follow-up period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	230
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
0.9% NaCl: Experimental	Drug: 0.9% NaCl Intravenous Fluid Isotonic Parenteral Fluid
0.45% NaCl: Active Comparator	Drug: 0.45%NaCl Intravenous Fluid Hypotonic Parenteral Fluid

Detailed Description:

Research Question:

In general pediatric surgical patients, do isotonic PMS compared to hypotonic PMS, result in a lower risk of acute hospital acquired plasma sodium derangements, occurring at any time during the study intervention? Primary efficacy objective -To determine the impact of postoperative administration of isotonic compared to hypotonic PMS on the risk of hospital acquired PNa derangements in pediatric surgical patients, occurring at any time during the study intervention. Secondary efficacy objectives: a) To determine the impact of postoperative administration of isotonic compared to hypotonic PMS on clinical sequelae related to acute PNa changes, in pediatric surgical patients. b) the independent predictors of hospital acquired PNa derangements will be explored.

Study Design:

This is a double-blind randomized controlled trial. Participants, health care providers, data collectors, and judicial assessors of outcomes will be blinded to the study intervention. Setting: McMaster Children's Hospital.

Trial Intervention:

Enrolled patients will be randomized postoperatively to receive either one of the following parenteral maintenance solutions: 1) hypotonic PMS, or 2) isotonic PMS. For the purposes of this study the hypotonic PMS will be 0.45%NaCl, and the Isotonic PMS will be 0.9% NaCl. Enrolled patients will receive their allocated treatment (provided there are no safety issues or concerns) until they are fully orally fed and the PMS rate is no greater than a rate required to "keep vein open (KVO)", to a maximum duration of 48 hours. The physician can thereafter administer the maintenance solution of their choice. The following parameters will be monitored in each study participant during the treatment period: hourly urine output, strict intake and output, 12 hourly fluid balances and daily weights. Blood and urine samples will be obtained on study patients every 12 hours until they are fully orally fed and the IV rate is at KVO, for a maximum of 48 hours. Any additional investigations ordered by the caring physician during the treatment and follow up period will also be recorded.

Patients will be followed for clinical outcomes for 48 hours after the study intervention is discontinued, or until the time of discharge.

Eligibility

Ages Eligible for Study:	6 Months to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734214

Contacts

Contact: Karen Choong

905 5212100 ext 75617

Locations

Canada, Ontario
McMaster Children's Hospital	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Principal Investigator: Karen Choong, MB, BCh, Msc
Sub-Investigator: Steven Arora, MD
Sub-Investigator: Mark Walton, MD
Sub-Investigator: Desigen Reddy, MB

Sponsors and Collaborators

Hamilton Health Sciences

Investigators

Principal Investigator:

Karen Choong, MB, BCh, MSc

McMaster University

More Information

No publications provided

Responsible Party:	McMaster University ( Dr. Karen Choong )
Study ID Numbers:	07-265
Study First Received:	August 12, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00734214 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

Parenteral Fluids
Isotonic
Hypotonic
Pediatric
Fluid overload

Study placed in the following topic categories:

Metabolic Diseases
Hyponatremia
Hypernatremia
Water-Electrolyte Imbalance
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Hyponatremia
Hypernatremia
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on September 04, 2009