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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

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Sickle Cell Crisis Device: Astoflo Plus fluid warmer Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Impact of Warmed Intravenous Saline in Sickle Cell Patients With Vaso-Occlusive Episodes
Study Start Date : November 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Warm fluid
Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer
Device: Astoflo Plus fluid warmer
A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius

No Intervention: Room temperature Fluid
Patients receive intravenous saline at room temperature (22-24 degrees Celsius)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. Time to Disposition [ Time Frame: 4 hours ]
    The amount of time spent in the ED was recorded for each patient

  3. 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

  4. 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).



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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316366


Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Renee Quarrie, MD Nationwide Childrens Hospital

Publications:

Responsible Party: Renee Quarrie, Attending, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02316366     History of Changes
Other Study ID Numbers: IRB12-00295
First Posted: December 12, 2014    Key Record Dates
Results First Posted: August 31, 2015
Last Update Posted: October 31, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn