A Trial Comparing Treatment With the Springfusor Infusion Pump to the IV Magnesium Sulfate Regimen

A Randomized Open-label Study to Compare the Clinical Outcomes and Magnesium Serum Concentrations Obtained in the Treatment of Severe Preeclampsia With a Repeat Bolus Intravenous Magnesium Sulfate Regimen Administered With the Springfusor Infusion Pump to a Continuous Intravenous Magnesium Sulfate Regimen

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02091401

Enrollment

200

Registered

2014-03-19

Start date

2015-01-31

Completion date

2016-02-29

Last updated

2016-10-04

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

Conditions

Preeclampsia

Keywords

magnesium sulfate

Brief summary

The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate administered by the Springfusor® controlled pump to a continuous intravenous regimen. The goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the continuous intravenous and Springfusor repeat bolus regimens. The study will also document the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.

Interventions

DEVICESpringfusor infusion pump

OTHERIV administration

DRUGMagnesium Sulfate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

Exhibit systolic blood pressure \> 160mm Hg OR a diastolic pressure \> 110 mm Hg (at two times over 30 minutes) (A single higher pressure could be accepted if the clinical team felt that magnesium sulfate therapy should be initiated without waiting 30 minutes). Exhibit proteinuria \> 1+; Have not given birth, or be \<24h postpartum Be assessed by enrolling physician to benefit from magnesium sulfate therapy Agree to comply with study procedures Be \> 18 years of age Give informed consent for study participation

Exclusion criteria

Eclamptic or seizing at the time of enrollment Received magnesium sulfate therapy 24h prior to study enrollment Known serum creatinine \>1.2 mg/dL. (Subject may be enrolled prior to knowledge of serum creatinine but would be withdrawn if \>1.2 mg/dL in order to have a proper dose adjustment.

Design outcomes

Primary

Measure	Time frame	Description
Magnesium concentration	00:00, 00:20; 00:40; 1:20; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00	Blood draw times will be structured so as to perform a robust population PK analysis. Time zero is the end of the bolus administration. In the Springfusor arm, samples will be collected at the following times: 00:00, 00:20; 00:40; 1:20; 2:00; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00. In the IV arm, samples will be collected at the following times: 0:00; 00:20; 00:40;1:00; 1:20; 1:40; 2:20; 3:00; 3:40; 4:20; 5:20; 6:40; 8:00; 9:20; 10:40 and 12:00.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026