Ignite Creation Date:
2024-05-05 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00530270
Status:
TERMINATED
Last Update Posted:
2013-04-09
First Post:
2007-09-14
Brief Title:
Dexamethasone to Treat Acute Chest Syndrome in People With Sickle Cell Disease
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Randomized Trial of Oral Dexamethasone for Acute Chest Syndrome
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was closed June 23 2008 due to low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People with sickle cell disease SCD may develop acute chest syndrome ACS which is a common and serious lung condition that usually requires hospitalization Dexamethasone is a medication that may decrease hospitalization time for people with ACS but it may also bring about new sickle cell pain This study will evaluate the effectiveness of a dexamethasone regimen that includes a gradual dose reduction at decreasing hospitalization and recovery time in people with SCD and ACS
Detailed Description:
SCD is an inherited blood disorder Symptoms include anemia infections organ damage and intense episodes of pain which are called sickle cell crises ACS is a life-threatening lung-related complication of SCD that can lower the level of oxygen in the blood Repeat occurrences of ACS can cause lung damage It is the second most common cause of hospitalizations among people with SCD and accounts for more than 25 of premature deaths in people with SCD Symptoms of ACS include fever chest pain cough and breathing difficulties ACS can appear suddenly and often requires immediate hospitalization and treatment including antibiotics supplemental oxygen and blood transfusions Previous studies have shown that dexamethasone a type of steroid medication that blocks inflammation can decrease hospitalization time for people with ACS however some participants in these earlier studies were re-hospitalized due to new sickle cell pain Slowly decreasing the dosage of dexamethasone over a period of time may decrease the chance that new sickle cell pain will occur The purpose of this study is to evaluate the effectiveness of a dexamethasone regimen that includes a gradual dose reduction at decreasing hospitalization and recovery time in people with SCD and ACS
This study will enroll people with SCD who are hospitalized and have been diagnosed with ACS within the past 24 hours Participants will be randomly assigned to receive either dexamethasone or placebo on a daily basis for 8 days Every 2 days the medication dose will be gradually reduced While in the hospital participants will receive usual care for ACS including antibiotics pain control medication intravenous fluids and other needed treatments Each day participants will undergo a physical exam a pain assessment score a test to measure the oxygen level in the body blood collection and if needed a chest x-ray Vital signs and blood pressure measurements will be taken every 4 hours Study staff will document the amount of pain medication blood transfusions oxygen and breathing treatments participants receive
Upon leaving the hospital follow-up visits will occur 1 week after participants were originally admitted to the hospital participants who are still hospitalized at this time will not attend this visit and 1 month after hospital discharge At both visits information on hospital visits for pain treatment and blood transfusions will be collected and evaluations performed earlier in the study will be repeated The second visit will also include lung function tests
This study will enroll people with SCD who are hospitalized and have been diagnosed with ACS within the past 24 hours Participants will be randomly assigned to receive either dexamethasone or placebo on a daily basis for 8 days Every 2 days the medication dose will be gradually reduced While in the hospital participants will receive usual care for ACS including antibiotics pain control medication intravenous fluids and other needed treatments Each day participants will undergo a physical exam a pain assessment score a test to measure the oxygen level in the body blood collection and if needed a chest x-ray Vital signs and blood pressure measurements will be taken every 4 hours Study staff will document the amount of pain medication blood transfusions oxygen and breathing treatments participants receive
Upon leaving the hospital follow-up visits will occur 1 week after participants were originally admitted to the hospital participants who are still hospitalized at this time will not attend this visit and 1 month after hospital discharge At both visits information on hospital visits for pain treatment and blood transfusions will be collected and evaluations performed earlier in the study will be repeated The second visit will also include lung function tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54HL070587 | NIH | None | None |
| U54HL070587-07 | NIH | None | httpsreporternihgovquickSearchU54HL070587-07 |