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PROtecting Maternal Brains From Injury and Stroke (PROMIS)

Primary Purpose

Preeclampsia, Maternal Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIRS based personalized blood pressure management
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia focused on measuring Pregnancy, Near-Infrared Spectroscopy (NIRS), Preeclampsia, Maternal health

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Aged 18 or older, within 6 weeks postpartum after a pregnancy lasting at least 20 weeks. Admitted to the inpatient obstetrics unit for treatment of preeclampsia with one or both of the following severe features: measured systolic BP ≥160 mmHg and/or diastolic BP ≥110 mmHg on two or more occasions, 15 minutes apart OR severe headache refractory to standard over-the-counter medications (acetaminophen, ibuprofen) Exclusion Criteria: Acute ischemic stroke Acute intracerebral or subarachnoid hemorrhage · Eclamptic seizures Any other neurological complication requiring transfer to the neurological intensive care unit or stroke step-down unit Prior history of stroke, seizures, traumatic brain injury, brain surgery, encephalitis, or demyelinating brain disease History of Reynaud's syndrome (contraindication to finger plethysmography) Inability to understand and consent to the study

Sites / Locations

  • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observational Cohort

Interventional

Arm Description

Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters

Autoregulation-guided blood pressure management for 24 hours. Blood pressure will be measured every four hours by arm cuff; however, in lieu of predetermined blood pressure treatment thresholds, an optimal mean arterial pressure (MAP) range will be chosen based on limits of autoregulation calculated in real-time for the previous four hours for each participant. Choice of medications and dosing will be left to the primary clinical obstetrics team.

Outcomes

Primary Outcome Measures

Percentage of time mean arterial pressure (MAP) is in the target range
The total time (in minutes) each participant had their mean arterial blood pressure (MAP) values within their computed limits of autoregulation will be measured. The primary outcome is the percentage of time the MAP is within the personalized limits of autoregulation.

Secondary Outcome Measures

Number of participants with neurological symptoms
Number of participants with neurological symptoms. Neurological symptoms defined as ≥8/10 headache pain or blurred vision.
Number of participants with physiological biomarker evidence of cerebral hypoperfusion
Tissue oxygenation index (TOI) is defined as the ratio of oxygenated to total tissue hemoglobin as measured by NIRS. After initial securing of Foresight cerebral forehead oximetry adhesive stickers, baseline TOI will be recorded after two minutes of monitoring. Hypoperfusion will be defined as >13% decrease from baseline TOI.
Number of participants with physiological biomarker evidence of cerebral hyperperfusion
Tissue oxygenation index (TOI) is defined as the ratio of oxygenated to total tissue hemoglobin as measured by NIRS. After initial securing of Foresight cerebral forehead oximetry adhesive stickers, baseline TOI will be recorded after two minutes of monitoring. Hyperperfusion will be defined as a >2% increase from baseline TOI.

Full Information

First Posted
February 3, 2023
Last Updated
May 8, 2023
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT05726279
Brief Title
PROtecting Maternal Brains From Injury and Stroke
Acronym
PROMIS
Official Title
PROtecting Maternal Brains From Injury and Stroke (PROMIS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to test a new approach to blood pressure management in postpartum preeclampsia. There will be two groups of patients in this early stage single center trial. Both groups of study participants (observational and interventional) will be treated with standard blood pressure medications while undergoing continuous non-invasive blood pressure and near infrared spectroscopy (NIRS) monitoring for 24 hours. The interventional group will have personalized blood pressure targets according to results of NIRS monitoring which will be updated in real time.
Detailed Description
Maternal neurological complications are a leading cause of postpartum severe maternal morbidity and maternal mortality (SMM/MM). The lack of biomarkers to identify women at highest risk of these rare, but devastating postpartum complications, including stroke, seizures, and posterior reversible encephalopathy syndrome, has impeded efforts to prevent neurological SMM/MM. Impaired cerebral autoregulation may be such a biomarker. Preliminary results using transcranial Doppler (TCD) based techniques to quantify cerebral autoregulation have demonstrated severely impaired cerebral autoregulation in the postpartum period in some women. However, TCD is operator dependent, and cannot be used for extended monitoring due to discomfort. In contrast, near-infrared spectroscopy (NIRS) is fully automated and can be continued for hours at the bedside. Identifying personalized blood pressure (BP) targets using NIRS has been shown to improve outcomes in acute stroke patients, another population with impaired cerebral autoregulation. However, this method has not been applied in postpartum women. The investigators are applying this novel approach to the management of postpartum preeclampsia (PEC) in a single-center, Phase II clinical trial, PROMIS (PROtecting Maternal brains from Injury and Stroke).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Maternal Hypertension
Keywords
Pregnancy, Near-Infrared Spectroscopy (NIRS), Preeclampsia, Maternal health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observational Cohort
Arm Type
No Intervention
Arm Description
Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Autoregulation-guided blood pressure management for 24 hours. Blood pressure will be measured every four hours by arm cuff; however, in lieu of predetermined blood pressure treatment thresholds, an optimal mean arterial pressure (MAP) range will be chosen based on limits of autoregulation calculated in real-time for the previous four hours for each participant. Choice of medications and dosing will be left to the primary clinical obstetrics team.
Intervention Type
Device
Intervention Name(s)
NIRS based personalized blood pressure management
Intervention Description
In lieu of predetermined blood pressure treatment thresholds, an optimal MAP range will be chosen based on limits of autoregulation calculated in real-time for the previous four hours for each participant. Choice of medications and dosing will be left to the primary clinical obstetrics team.
Primary Outcome Measure Information:
Title
Percentage of time mean arterial pressure (MAP) is in the target range
Description
The total time (in minutes) each participant had their mean arterial blood pressure (MAP) values within their computed limits of autoregulation will be measured. The primary outcome is the percentage of time the MAP is within the personalized limits of autoregulation.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of participants with neurological symptoms
Description
Number of participants with neurological symptoms. Neurological symptoms defined as ≥8/10 headache pain or blurred vision.
Time Frame
24 hours
Title
Number of participants with physiological biomarker evidence of cerebral hypoperfusion
Description
Tissue oxygenation index (TOI) is defined as the ratio of oxygenated to total tissue hemoglobin as measured by NIRS. After initial securing of Foresight cerebral forehead oximetry adhesive stickers, baseline TOI will be recorded after two minutes of monitoring. Hypoperfusion will be defined as >13% decrease from baseline TOI.
Time Frame
24 hours
Title
Number of participants with physiological biomarker evidence of cerebral hyperperfusion
Description
Tissue oxygenation index (TOI) is defined as the ratio of oxygenated to total tissue hemoglobin as measured by NIRS. After initial securing of Foresight cerebral forehead oximetry adhesive stickers, baseline TOI will be recorded after two minutes of monitoring. Hyperperfusion will be defined as a >2% increase from baseline TOI.
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 or older, within 6 weeks postpartum after a pregnancy lasting at least 20 weeks. Admitted to the inpatient obstetrics unit for treatment of preeclampsia with one or both of the following severe features: measured systolic BP ≥160 mmHg and/or diastolic BP ≥110 mmHg on two or more occasions, 15 minutes apart OR severe headache refractory to standard over-the-counter medications (acetaminophen, ibuprofen) Exclusion Criteria: Acute ischemic stroke Acute intracerebral or subarachnoid hemorrhage · Eclamptic seizures Any other neurological complication requiring transfer to the neurological intensive care unit or stroke step-down unit Prior history of stroke, seizures, traumatic brain injury, brain surgery, encephalitis, or demyelinating brain disease History of Reynaud's syndrome (contraindication to finger plethysmography) Inability to understand and consent to the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eliza Miller, MD, MS
Phone
212-305-8389
Email
ecm2137@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Noora Haghighi
Phone
212-305-8389
Email
nh2716@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliza Miller, MD, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eliza Miller, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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PROtecting Maternal Brains From Injury and Stroke

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