Sickle Cell DiseaseNCT02316366
The Use of Warmed Saline in Vaso-occlusive Episodes
A study testing Astoflo Plus fluid warmer in people with Sickle Cell Disease and Sickle Cell Crisis, run by Nationwide Children's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell Crisis
- What is being tested?
- Astoflo Plus fluid warmer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Clinical Impact of Warmed Intravenous Saline in Sickle Cell Patients With Vaso-Occlusive Episodes
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.
Read the 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.
- Conditions
- Sickle Cell Disease, Sickle Cell Crisis
- Being tested
- Astoflo Plus fluid warmer
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astoflo Plus fluid warmerDevice
A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius
| Study group | Role | What they receive |
|---|---|---|
| Warm fluid | Experimental | Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer Receives: Device: Astoflo Plus fluid warmer |
| Room temperature Fluid | No intervention | Patients receive intravenous saline at room temperature (22-24 degrees Celsius) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Secondary outcomes (4)
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)
Measured: 4 hours
Time to Disposition
The amount of time spent in the ED was recorded for each patient
Measured: 4 hours
Amount of Narcotic Administered
The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient
Measured: 4 hours
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).
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renee Quarrie, Nationwide Children's Hospital
- Investigators
- Renee Quarrie, MD, Principal investigator, Nationwide Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316366
- Sponsor's protocol ID
- IRB12-00295
- Status last verified
- Oct 2018
- First submitted
- 10 Dec 2014
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21584938Mousa 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.
PubMed 20530056Raphael 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.
PubMed 18300322Raphael 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.
PubMed 18383165Field 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.
PubMed 19295432Mehta 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.
PubMed 16883928Platt 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.
PubMed 1710777Conran 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.
PubMed 19205968Jaja 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.
PubMed 12717457
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Warmed Intravenous Saline in Sickle Cell Patients With Vaso-Occlusive Episodes
- ClinicalTrials.gov ID
- NCT02316366
- Acronym / sponsor ID
- IRB12-00295
- Conditions
- Sickle Cell Disease, Sickle Cell Crisis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Posted 31 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm fluid | Experimental | Device: Astoflo Plus fluid warmerPatients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer |
| Room temperature Fluid | No intervention | –Patients receive intravenous saline at room temperature (22-24 degrees Celsius) |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astoflo Plus fluid warmerA fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius | Device | Warm fluid |
Primary outcome
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.
4 secondary outcomes
Difference in Pain Score
Time frame: 4 hours
Time to Disposition
Time frame: 4 hours
Amount of Narcotic Administered
Time frame: 4 hours
Global Comfort
Time frame: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21584938Raphael 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.
- Background: PubMed 20530056Mousa 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.
- Background: PubMed 18300322Raphael 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.
- Background: PubMed 18383165Raphael 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.
- Background: PubMed 19295432Field 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.
- Background: PubMed 16883928Mehta 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.
- Background: PubMed 1710777Platt 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.
- Background: PubMed 19205968Conran 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.
- Background: PubMed 12717457Jaja 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renee Quarrie, MD principal investigator
Nationwide Childrens Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Astoflo Plus fluid warmer in people with Sickle Cell Disease and Sickle Cell Crisis, run by Nationwide Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Hospital Admission (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02316366, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.