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

Phase 4

Completed

• Conditions: Preeclampsia
• Interventions: Other: IV administration; Device: Springfusor infusion pump; Drug: Magnesium Sulfate

• Registration Number: NCT02091401
• Lead Sponsor: Gynuity Health Projects

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-19
• Study Start: 2015-01
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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 (Subject may be enrolled prior to knowledge of serum creatinine but would be withdrawn if 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV	IV administration	Women randomized into this treatment group will receive magnesium sulfate via an IV loading dose administered manually by study staff and an IV maintenance regimen.
Springfusor	Springfusor infusion pump	Women randomized into this treatment group will receive magnesium sulfate via IV infusion (with the Springfusor® pump).
IV	Magnesium Sulfate	Women randomized into this treatment group will receive magnesium sulfate via an IV loading dose administered manually by study staff and an IV maintenance regimen.
Springfusor	Magnesium Sulfate	Women randomized into this treatment group will receive magnesium sulfate via IV infusion (with the Springfusor® pump).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

El Galaa Teaching Hospital; 🇪🇬 Cairo, Egypt

Shatby Maternity Hospital; 🇪🇬 Alexandria, Egypt