Treatment of Severe Hypertension With ICG Directed Therapy

Treatment of Severe Hypertension With Impendence Cardiography (ICG) Directed Therapy; a Randomized Controlled Trial

The purpose of the study is to compare the usefulness of Impedence Cardiography (ICG) directed therapy in treating severe range hypertension in pregnant women at term.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension in Pregnancy
• Intervention / Treatment: Diagnostic test: Impendence Cardiography

Detailed Description

Research Protocol

Study Design: Randomized Control Trial This is a randomized control trial comparing the usefulness of impedance cardiography (ICG) directed therapy in treating severe range hypertension (systolic BP >160 OR diastolic BP >110) in patients greater than 20 weeks gestation. All patients in the study will receive standard of care medication within the suggested timeframe by the American College of Obstetrics and Gynecology (ACOG). All patients will receive a hemodynamic assessment prior to receiving and after receiving medications. The treatment patients will receive either labetalol or nifedipine therapy for hypertension based on their hemodynamic parameters. The control group will receive medication based on provider preference (which is the usual plan of care).

Study Population:

Patients presenting to Labor and Delivery at Cabell Huntington Hospital being treated for severe range blood pressures. Consent will be obtained prior to randomization to standard care or ICG directed care. Patient age range will be from age 15 to approximately 45.

Schedule of Assessment:

An interval assessment will be performed after 20 patients have been assessed. The goal is for a total enrollment of 100 patients, 50 to the ICG directed treatment group and 50 to the control group.

Study Procedures:

If a patient presents to Labor and Delivery at Cabell Huntington Hospital and consents to the study, she will be randomized to either the ICG directed therapy group or provider preference group. Patients from each group will receive a non-invasive hemodynamic assessment via the NICaS system. The NICaS system uses impedance cardiography which provides a reliable assessment of cardiovascular, respiratory, and fluid parameters. The vasodilator nifedipine will be initiated for increased systemic vascular resistance. Elevated cardiac output will be treated with beta blockade via IV labetalol. ACOG recommends either of these medications as first line therapy for elevated blood pressure, and offers no guidance on which medication should be used first. All patients who are being treated will receive the standard of care treatment, however the ICG group will receive therapy based on their hemodynamic parameters.

Study Analysis The control group will be compared to the ICG directed treatment group.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Cabell Huntington Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 43 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients presenting to Labor and Delivery at Cabell Huntington Hospital being treated for severe range blood pressure after 20 weeks gestation. Patients will be English speaking and range in ages from 15-45 years old. Patient's will be consented prior to randomization.

Exclusion Criteria:

• Patients presenting to Labor and Delivery at Cabell Huntington Hospital with normal range blood pressures, or those with elevated blood pressures who do not consent to the study, patients <20 weeks gestation, or patients with eclampsia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Provider preference: Control group; Provider will prescribe blood pressure medication based on his professional expertise.
Experimental: ICG directed therapy group; ICG directed therapy will be used to determine which blood pressure medication is received.	Diagnostic test: Impendence Cardiography; ICG is a noninvasive method of determining the amount of blood flow using the Non-Invasive Cardiac System - Cardiac Surveyor (NICaS) system, which provides an assessment of the cardiovascular system, respiratory system, and fluid retention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The systolic blood pressure	mmHg	1 year
The diastolic blood pressure	mmHg	1 year
mean arterial pressure	mmHg	1 year
heart rate	beats/minute	1 year
cardiac output (L/min)	liters per minute	1 year
systemic vascular resistance	dynes · sec/cm^-5	1 year

Collaborators and Investigators

• Sponsor: Marshall University
• Investigators: Principal Investigator: Jesse Cottrell, MD, Marshall University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 1605500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No