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The Use of Warmed Saline in Vaso-occlusive Episodes

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ClinicalTrials.gov Identifier: NCT02316366
Recruitment Status : Completed
First Posted : December 12, 2014
Results First Posted : August 31, 2015
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Renee Quarrie, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE December 10, 2014
First Posted Date  ICMJE December 12, 2014
Results First Submitted Date  ICMJE July 31, 2015
Results First Posted Date  ICMJE August 31, 2015
Last Update Posted Date October 31, 2018
Study Start Date  ICMJE November 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
Rate of Hospital Admission [ Time Frame: 4 hours ]
After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • Difference in Pain Score [ Time Frame: 4 hours ]
    During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided. The difference between the pain score upon arrival and at discharge was assessed. Minimum value 1, maximum value 10 (most pain)
  • Time to Disposition [ Time Frame: 4 hours ]
    The amount of time spent in the ED was recorded for each patient
  • Amount of Narcotic Administered [ Time Frame: 4 hours ]
    The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient
  • Global Comfort [ Time Frame: 4 hours ]
    Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay. Question 2 of the survey addressed comfort by asking: "On a scale of 1 to 5, how do you think the fluid made you feel?" (1 is worse and 5 is better).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
  • Pain Score [ Time Frame: 4 hours ]
    During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided.
  • Time to Disposition [ Time Frame: 4 hours ]
    The amount of time spent in the ED was recorded for each patient
  • Amount of Narcotic Administered [ Time Frame: 4 hours ]
    The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient
  • Global Comfort [ Time Frame: 4 hours ]
    Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Warmed Saline in Vaso-occlusive Episodes
Official Title  ICMJE Clinical Impact of Warmed Intravenous Saline in Sickle Cell Patients With Vaso-Occlusive Episodes
Brief Summary The purpose of this study is to determine if warming the intravenous (IV) fluid given to patients with Sickle Cell Disease who are experiencing painful episodes known as Vaso-Occlusive Episodes; will decrease rates of hospital admission, decrease amounts of IV pain medications given, improve pain and improve global comfort.
Detailed Description

Vaso-occlusive crisis (VOC) is a common painful complication of Sickle Cell Disease and is the primary reason that these patients seek medical care in the acute care setting. This complication arises when blood vessels are obstructed by sickled red blood cells resulting in ischemic injury.

The standard management of these painful episodes comprises the administration of opioid analgesics, the infusion of intravenous (IV) fluids at room temperature and rest. These episodes often last five to seven days and many patients require inpatient management for continued administration of intravenous analgesics.

The public health impact of the disease is large as admissions frequently result in school or work absences and can be financially and emotionally taxing.

It is well established that exposure to cold precipitates VOC. For this reason, management of the pain of VOC in some centers includes the use of warming blankets as an adjunct for pain relief. It is conceptually appealing to conjecture that warm fluids might have similar salutary effects on VOC. This conjecture is bolstered by the physiologic effect of temperature on vascular tone. Specifically, it is well established that cold temperatures cause vasoconstriction whereas warm temperatures cause vasodilation. We expect that warmed fluids will similarly induce vasodilation, improving blood flow to vaso-occluded ischemic areas.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sickle Cell Disease
  • Sickle Cell Crisis
Intervention  ICMJE Device: Astoflo Plus fluid warmer
A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius
Study Arms  ICMJE
  • Experimental: Warm fluid
    Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer
    Intervention: Device: Astoflo Plus fluid warmer
  • No Intervention: Room temperature Fluid
    Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2014)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Vaso-occlusive Episode defined as a pain rating of 3 or above on the Wong-Baker FACES score in a child with an established diagnosis of sickle cell disease (SS, SC or S β Thalassemia)
  • 4-21 years of age

Exclusion Criteria:

  • fever (temperature greater than 38 degrees Celsius)
  • inability to complete FACES pain scale
  • evidence of acute chest syndrome clinically or radiographically
  • deemed by attending physician to be so ill as to need immediate hospital admission.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02316366
Other Study ID Numbers  ICMJE IRB12-00295
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Renee Quarrie, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Renee Quarrie, MD Nationwide Childrens Hospital
PRS Account Nationwide Children's Hospital
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP