Trial · NCT00530270

Dexamethasone to Treat Acute Chest Syndrome in People With Sickle Cell Disease

NCT00530270, Phase 3, Terminated, Children's Hospital Medical Center, Cincinnati; results first posted 2009-12-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dexamethasone to Treat Acute Chest Syndrome in People With Sickle Cell Disease. Trials, record NCT00530270. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00530270

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dexamethasone to Treat Acute Chest Syndrome in People With Sickle Cell Disease
NCT number: NCT00530270
Status: Terminated
Phases: Phase 3
Enrollment: 12 participants, actual
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Conditions: Anemia, Sickle Cell
Interventions: Dexamethasone, Placebo
First posted: 2007-09-17
Last updated: 2013-04-09
Results first posted: 2009-12-31
Limitations and caveats: Primary limitation of this study is that is was terminated prior to enrolling all of the subjects necessary to address the primary question.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Log (Natural) of Duration of Signs and Symptoms of Acute Chest Syndrome (ACS) or Duration of Hospitalization, Whichever is Less	Measured from first dose to end of the hospital stay, no maximum number of days	Resolution of symptoms of ACS includes respiratory rate \<= upper limit of normal +2, no work of breathing (retractions, nasal flaring, and use of accessory muscles), thoracic pain \<= 4, no use of supplemental oxygen, no use of ventilary support, and saturation of peripheral oxygen (Sp02) \>= steady state value -2. Symptoms were measured every 4 hours from the first dose of study drug to resolution of symptoms or hospital discharge.
Secondary	Rating of Pain	Measured at the end of the hospital stay	Change from baseline rating of pain from randomization (baseline) to discharge from the hospital, evaluated every 4 hours. Pain was rated on the Oucher Scale for the pediatric population or numeric rating scale for the adult population, both 0 to 10 with 0 indicating no pain and 10 indicating severe pain.
Secondary	Duration of Hospitalization	Measured at the end of hospital stay, no maximum number of days	Duration in hours from treatment start time to hospital discharge.
Secondary	Duration of Supplemental Oxygen	Measured at the end of hospital stay	Time period between the supplemental oxygen start date/time and first dose date/time, whichever is later, and the supplemental oxygen stop date/time
Secondary	Duration of Hypoxemia (Low Blood Oxygen)	Measured at the end of hospital stay	Sum of time periods when subject was hypoxemic (Sp02 value less than 92%) since the first dose date/time

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Log (Natural) of Duration of Signs and Symptoms of Acute Chest Syndrome (ACS) or Duration of Hospitalization, Whichever is Less	Measured from first dose to end of the hospital stay, no maximum number of days	Subject without major protocol violation and received treatment.	hours (log transformed)	LOG_MEAN
SECONDARY	Rating of Pain	Measured at the end of the hospital stay	Subject without major protocol violation and received treatment.	Units on a scale	MEAN
SECONDARY	Duration of Hospitalization	Measured at the end of hospital stay, no maximum number of days	Subject without major protocol violation and received treatment.	Hours	MEAN
SECONDARY	Duration of Supplemental Oxygen	Measured at the end of hospital stay	Subject without major protocol violation and received treatment.	Hours	MEAN
SECONDARY	Duration of Hypoxemia (Low Blood Oxygen)	Measured at the end of hospital stay	Subject without major protocol violation and received treatment.	Hours	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Log (Natural) of Duration of Signs and Symptoms of Acute Chest Syndrome (ACS) or Duration of Hospitalization, Whichever is Less	Dexamethasone		2.4	Standard Deviation 1.23	hours (log transformed)
Log (Natural) of Duration of Signs and Symptoms of Acute Chest Syndrome (ACS) or Duration of Hospitalization, Whichever is Less	Placebo		3.5	Standard Deviation 0.60	hours (log transformed)
Rating of Pain	Dexamethasone	Thoracic	-3.8	Standard Error 1.34	Units on a scale
Rating of Pain	Placebo	Thoracic	-4.1	Standard Error 1.26	Units on a scale
Rating of Pain	Dexamethasone	Non-thoracic	-2.0	Standard Error 1.35	Units on a scale
Rating of Pain	Placebo	Non-thoracic	-1.4	Standard Error 1.28	Units on a scale
Duration of Hospitalization	Dexamethasone		41.5	Standard Deviation 9.03	Hours
Duration of Hospitalization	Placebo		62.3	Standard Deviation 14.27	Hours
Duration of Supplemental Oxygen	Dexamethasone		17.5	Standard Deviation 0	Hours
Duration of Supplemental Oxygen	Placebo		41.2	Standard Deviation 22.22	Hours

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dexamethasone	6
Overall Study	STARTED	Placebo	6
Overall Study	COMPLETED	Dexamethasone	5
Overall Study	COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Dexamethasone	1
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Sickle cell anemia with crisis	Congenital, familial and genetic disorders	Dexamethasone	3	6	3
other	Sickle cell anemia with crisis	Congenital, familial and genetic disorders	Placebo	0	6	0
other	Pyrexia	General disorders	Dexamethasone	2	6	2
other	Pyrexia	General disorders	Placebo	0	6	0
other	Pain	General disorders	Dexamethasone	1	6	1
other	Pain	General disorders	Placebo	0	6	0
other	Vomiting	Gastrointestinal disorders	Dexamethasone	0	6	0
other	Vomiting	Gastrointestinal disorders	Placebo	1	6	1
other	Insomnia	Psychiatric disorders	Dexamethasone	1	6	1
other	Insomnia	Psychiatric disorders	Placebo	0	6	0

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dexamethasone
Total, all-cause mortality	Placebo
Total, other adverse events	Dexamethasone	4	6
Total, other adverse events	Placebo	2	6
Total, serious adverse events	Dexamethasone	1	6
Total, serious adverse events	Placebo	0	6

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21848879	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U54HL070587	Statistics and Data Management Center-Comprehensive Sickle Cell Centers	KESLER, KAREN	RHO FEDERAL SYSTEMS DIVISION, INC.	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2003 to 2011

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Dexamethasone vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00530270

GET https://conductscience.org/api/trials/v1/NCT00530270/registered

API reference For AI assistants