Trial · NCT01197417

Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

NCT01197417, Phase 2, Phase 3, Completed, Medical College of Wisconsin; results first posted 2015-09-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis. Trials, record NCT01197417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01197417

On this page

Trial

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

Title: Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis
NCT number: NCT01197417
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 208 participants, actual
Lead sponsor: Medical College of Wisconsin
Conditions: Sickle Cell Disease
Interventions: Intravenous Magnesium Sulfate, Normal Saline Placebo
First posted: 2010-09-09
Last updated: 2016-01-27
Results first posted: 2015-09-07

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Hospital Length of Stay (Hours)	From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment
Secondary	Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization	Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment
Secondary	Hypotension Associated With Infusion	Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment	For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.
Secondary	Warm Sensation Associated With Study Drug Infusion	Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment	Patient spontaneously reported feelings of warmth during any study drug infusion.
Secondary	Rehospitalization	Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge)
Secondary	Development of Acute Chest Syndrome (ACS)	Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment
Secondary	Hospital Length of Stay	Start of first study drug infusion to actual hospital discharge

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Hospital Length of Stay (Hours)	From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment	All participants who received at least one dose of study drug and who did not withdraw from data collection prior to outcome	hours	MEDIAN
SECONDARY	Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization	Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment	All participants who received at least one dose of study drug and who did not withdraw from data collection prior to either hospital discharge or 12 hours after last intravenous opioid.	mg Morphine/kg	MEDIAN
SECONDARY	Hypotension Associated With Infusion	Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment	All participants who received at least one dose of study drug	Participant	NUMBER
SECONDARY	Warm Sensation Associated With Study Drug Infusion	Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment	All participants who received at least one dose of study drug.	Participant	NUMBER
SECONDARY	Rehospitalization	Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge)	All participants who received at least one dose of study drug who had known rehospitalization status within 7 days	Participant	NUMBER
SECONDARY	Development of Acute Chest Syndrome (ACS)	Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment		Paricipants	NUMBER
SECONDARY	Hospital Length of Stay	Start of first study drug infusion to actual hospital discharge		Hours	MEDIAN

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Value	Spread	Units
Hospital Length of Stay (Hours)	Magnesium Group	56	Inter-Quartile Range 27 to 109	hours
Hospital Length of Stay (Hours)	Placebo Group	47	Inter-Quartile Range 24 to 99	hours
Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization	Magnesium Group	1.46	Inter-Quartile Range 0.55 to 3.32	mg Morphine/kg
Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization	Placebo Group	1.28	Inter-Quartile Range 0.40 to 3.29	mg Morphine/kg
Hypotension Associated With Infusion	Magnesium Group	4		Participant
Hypotension Associated With Infusion	Placebo Group	1		Participant
Warm Sensation Associated With Study Drug Infusion	Magnesium Group	26		Participant
Warm Sensation Associated With Study Drug Infusion	Placebo Group	2		Participant
Rehospitalization	Magnesium Group	12		Participant
Rehospitalization	Placebo Group	7		Participant

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Magnesium Group	104
Overall Study	STARTED	Placebo Group	104
Overall Study	Received Study Drug	Magnesium Group	101
Overall Study	Received Study Drug	Placebo Group	103
Overall Study	COMPLETED	Magnesium Group	96
Overall Study	COMPLETED	Placebo Group	86
Overall Study	NOT COMPLETED	Magnesium Group	8
Overall Study	NOT COMPLETED	Placebo Group	18

Source ClinicalTrials.gov

Adverse events40

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	Acute chest syndrome	Blood and lymphatic system disorders	Magnesium Group	6	101	6
other	Acute chest syndrome	Blood and lymphatic system disorders	Placebo Group	7	103	7
other	Anemia	Blood and lymphatic system disorders	Magnesium Group	7	101	7
other	Anemia	Blood and lymphatic system disorders	Placebo Group	7	103	7
other	Constipation	Gastrointestinal disorders	Magnesium Group	8	101	8
other	Constipation	Gastrointestinal disorders	Placebo Group	11	103	11
other	Emesis	Gastrointestinal disorders	Magnesium Group	10	101	10
other	Emesis	Gastrointestinal disorders	Placebo Group	9	103	9
other	Nausea	Gastrointestinal disorders	Magnesium Group	16	101	16
other	Nausea	Gastrointestinal disorders	Placebo Group	19	103	20

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Magnesium Group
Total, all-cause mortality	Placebo Group
Total, other adverse events	Magnesium Group	66	101
Total, other adverse events	Placebo Group	62	103
Total, serious adverse events	Magnesium Group	13	101
Total, serious adverse events	Placebo Group	12	103

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24443249	DERIVED	PubMed
26232172	RESULT	PubMed
28606098	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons1

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

Comparison
Magnesium Group vs Placebo Group: 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/NCT01197417

GET https://conductscience.org/api/trials/v1/NCT01197417/events?page=2

API reference For AI assistants