Skip to content

The Use of Warmed Saline in Vaso-occlusive Episodes

Clinical Impact of Warmed Intravenous Saline in Sickle Cell Patients With Vaso-Occlusive Episodes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02316366
Enrollment
80
Registered
2014-12-12
Start date
2012-11-30
Completion date
2014-06-30
Last updated
2018-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Crisis, Sickle Cell Disease

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.

Interventions

DEVICEAstoflo Plus fluid warmer

A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 21 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of Hospital Admission4 hoursAfter 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

MeasureTime frameDescription
Difference in Pain Score4 hoursDuring 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 Disposition4 hoursThe amount of time spent in the ED was recorded for each patient
Amount of Narcotic Administered4 hoursThe amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient
Global Comfort4 hoursUpon 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).

Participant flow

Participants by arm

ArmCount
Warm Fluid
Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius
40
Room Temperature Fluid
Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
40
Total80

Baseline characteristics

CharacteristicWarm FluidRoom Temperature FluidTotal
Age, Continuous14.3 years
STANDARD_DEVIATION 4.7
13.6 years
STANDARD_DEVIATION 5.6
14 years
STANDARD_DEVIATION 5.1
Region of Enrollment
United States
40 participants40 participants80 participants
Sex: Female, Male
Female
19 Participants23 Participants42 Participants
Sex: Female, Male
Male
21 Participants17 Participants38 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 400 / 40
serious
Total, serious adverse events
0 / 400 / 40

Outcome results

Primary

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.

Time frame: 4 hours

ArmMeasureValue (NUMBER)
Warm FluidRate of Hospital Admission63 percentage of participants
Room Temperature FluidRate of Hospital Admission55 percentage of participants
Secondary

Amount of Narcotic Administered

The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient

Time frame: 4 hours

ArmMeasureValue (MEAN)
Warm FluidAmount of Narcotic Administered0.31 mg/kg
Room Temperature FluidAmount of Narcotic Administered0.3 mg/kg
Secondary

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 frame: 4 hours

ArmMeasureValue (MEAN)Dispersion
Warm FluidDifference in Pain Score-2.6 units on a scaleStandard Error 3.5
Room Temperature FluidDifference in Pain Score-2.9 units on a scaleStandard Error 3.4
Secondary

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).

Time frame: 4 hours

ArmMeasureValue (MEDIAN)
Warm FluidGlobal Comfort4 units on a scale
Room Temperature FluidGlobal Comfort3 units on a scale
Secondary

Time to Disposition

The amount of time spent in the ED was recorded for each patient

Time frame: 4 hours

ArmMeasureValue (MEAN)
Warm FluidTime to Disposition158 minutes
Room Temperature FluidTime to Disposition155 minutes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026