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
About this trial
This is an interventional treatment trial for Sickle Cell Disease
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.
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
NCT ID
NCT02316366
First Posted
December 10, 2014
Last Updated
October 4, 2018
Sponsor
Nationwide Children's Hospital
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
background
Learn more about this trial
The Use of Warmed Saline in Vaso-occlusive Episodes
We'll reach out to this number within 24 hrs