Treatment of Severe Hypertension With ICG Directed Therapy

NCT ID: NCT04748107

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-25
• Study Completion Date: 2023-06-01

Brief Summary

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.

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.

Conditions

Hypertension in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Provider preference: Control group

Provider will prescribe blood pressure medication based on his professional expertise.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ICG directed therapy group

ICG directed therapy will be used to determine which blood pressure medication is received.

Group Type: EXPERIMENTAL

Impendence Cardiography

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Marshall University

OTHER

Sponsor Role: lead

Responsible Party

Jesse Cottrell

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesse Cottrell, MD

Role: PRINCIPAL_INVESTIGATOR

Marshall University

Locations

Cabell Huntington Hospital

Huntington, West Virginia, United States

Countries

United States

Other Identifiers

1605500

Identifier Type: -

Identifier Source: org_study_id