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The Use of Warmed Saline in Vaso-occlusive Episodes

Primary Purpose

Sickle Cell Disease, Sickle Cell Crisis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Astoflo Plus fluid warmer
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

4 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Warm fluid

    Room temperature Fluid

    Arm Description

    Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer

    Patients receive intravenous saline at room temperature (22-24 degrees Celsius)

    Outcomes

    Primary Outcome Measures

    Rate of Hospital Admission
    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

    Difference in Pain Score
    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
    The amount of time spent in the ED was recorded for each patient
    Amount of Narcotic Administered
    The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient
    Global Comfort
    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).

    Full Information

    First Posted
    December 10, 2014
    Last Updated
    October 4, 2018
    Sponsor
    Nationwide Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02316366
    Brief Title
    The Use of Warmed Saline in Vaso-occlusive Episodes
    Official Title
    Clinical Impact of Warmed Intravenous Saline in Sickle Cell Patients With Vaso-Occlusive Episodes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nationwide Children's Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sickle Cell Disease, Sickle Cell Crisis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Warm fluid
    Arm Type
    Experimental
    Arm Description
    Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer
    Arm Title
    Room temperature Fluid
    Arm Type
    No Intervention
    Arm Description
    Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
    Intervention Type
    Device
    Intervention Name(s)
    Astoflo Plus fluid warmer
    Intervention Description
    A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius
    Primary Outcome Measure Information:
    Title
    Rate of Hospital Admission
    Description
    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.
    Time Frame
    4 hours
    Secondary Outcome Measure Information:
    Title
    Difference in Pain Score
    Description
    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 Frame
    4 hours
    Title
    Time to Disposition
    Description
    The amount of time spent in the ED was recorded for each patient
    Time Frame
    4 hours
    Title
    Amount of Narcotic Administered
    Description
    The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient
    Time Frame
    4 hours
    Title
    Global Comfort
    Description
    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).
    Time Frame
    4 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Renee Quarrie, MD
    Organizational Affiliation
    Nationwide Childrens Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21584938
    Citation
    Raphael JL, Mei M, Mueller BU, Giordano T. High resource hospitalizations among children with vaso-occlusive crises in sickle cell disease. Pediatr Blood Cancer. 2012 Apr;58(4):584-90. doi: 10.1002/pbc.23181. Epub 2011 May 16.
    Results Reference
    background
    PubMed Identifier
    20530056
    Citation
    Mousa SA, Al Momen A, Al Sayegh F, Al Jaouni S, Nasrullah Z, Al Saeed H, Alabdullatif A, Al Sayegh M, Al Zahrani H, Hegazi M, Al Mohamadi A, Alsulaiman A, Omer A, Al Kindi S, Tarawa A, Al Othman F, Qari M. Management of painful vaso-occlusive crisis of sickle-cell anemia: consensus opinion. Clin Appl Thromb Hemost. 2010 Aug;16(4):365-76. doi: 10.1177/1076029609352661. Epub 2010 Jun 7.
    Results Reference
    background
    PubMed Identifier
    18300322
    Citation
    Raphael JL, Kamdar A, Wang T, Liu H, Mahoney DH, Mueller BU. Day hospital versus inpatient management of uncomplicated vaso-occlusive crises in children with sickle cell disease. Pediatr Blood Cancer. 2008 Sep;51(3):398-401. doi: 10.1002/pbc.21537.
    Results Reference
    background
    PubMed Identifier
    18383165
    Citation
    Raphael JL, Kamdar A, Beavers MB, Mahoney DH, Mueller BU. Treatment of uncomplicated vaso-occlusive crises in children with sickle cell disease in a day hospital. Pediatr Blood Cancer. 2008 Jul;51(1):82-5. doi: 10.1002/pbc.21483.
    Results Reference
    background
    PubMed Identifier
    19295432
    Citation
    Field JJ, Knight-Perry JE, Debaun MR. Acute pain in children and adults with sickle cell disease: management in the absence of evidence-based guidelines. Curr Opin Hematol. 2009 May;16(3):173-8. doi: 10.1097/MOH.0b013e328329e167.
    Results Reference
    background
    PubMed Identifier
    16883928
    Citation
    Mehta SR, Afenyi-Annan A, Byrns PJ, Lottenberg R. Opportunities to improve outcomes in sickle cell disease. Am Fam Physician. 2006 Jul 15;74(2):303-10.
    Results Reference
    background
    PubMed Identifier
    1710777
    Citation
    Platt OS, Thorington BD, Brambilla DJ, Milner PF, Rosse WF, Vichinsky E, Kinney TR. Pain in sickle cell disease. Rates and risk factors. N Engl J Med. 1991 Jul 4;325(1):11-6. doi: 10.1056/NEJM199107043250103.
    Results Reference
    background
    PubMed Identifier
    19205968
    Citation
    Conran N, Franco-Penteado CF, Costa FF. Newer aspects of the pathophysiology of sickle cell disease vaso-occlusion. Hemoglobin. 2009;33(1):1-16. doi: 10.1080/03630260802625709.
    Results Reference
    background
    PubMed Identifier
    12717457
    Citation
    Jaja SI, Gbadamosi TA, Kehinde MO, Gbenebitse S. The effect of warmth or/and vitamin E supplementation on forearm blood flow and forearm vascular resistance in sickle cell and non sickle cell anaemia subjects. Niger Postgrad Med J. 2003 Mar;10(1):6-12.
    Results Reference
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    The Use of Warmed Saline in Vaso-occlusive Episodes

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