Immediate Pressor Response to Oral Salt (IPROS)

January 18, 2024 updated by: Sepiso K. Masenga, Mulungushi University

Diagnostic Accuracy of Using an Immediate Pressor Response to Oral Salt (IPROS) to Identify Salt Sensitivity of Blood Pressure (SSBP): a Time Series Clinical Trial

The goal of this study is to establish a diagnostic accuracy of an immediate pressor response to oral salt (IPROS) to identify salt sensitivity of blood pressure (SSBP)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants are given dietary salt and their BP is measured every 10 minutes for 2 hours. IPROS is diagnosed with significant mean arterial pressure increase

For SSBP, participants are put on high salt diet for a week and monitored and low salt week. The Mean arterial pressure difference between high salt and low salt is used to diagnose SSBP

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Zambia
      • Lusaka, Zambia, 10101
        • Recruiting
        • Kanyama General Hospital
        • Contact:
          • Chileleko Siakabanze, MSc
        • Principal Investigator:
          • Chileleko Siakabanze, MSc
    • Southern
      • Livingstone, Southern, Zambia, 10101
        • Not yet recruiting
        • Livingstone University Teaching Hospital
        • Contact:
          • Kaseya Chiyenu, MD
        • Principal Investigator:
          • Sepiso K Masenga, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants will be included if they are males or females, aged 18-65 years.

Exclusion Criteria:

  • Kidney disease, Cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
intervention given
Other: salt
After ≥8 hr overnight fasting, participants will be required to ingest 780 mg of sodium (2 g salt) and BP measured every 10 minutes for 2 hours to determine IPROS. For SSBP, Participants are put on low salt (50 mmol Na/day) followed by seven days of high salt diet (250 mmol Na/day). Participants' mean arterial pressure (MAP) difference between low- and high-salt diet will be used to define salt sensitivity (MAP≥8 mmHg) and salt resistance (MAP≤5 mmHg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SSBP
Time Frame: 2 weeks
Salt sensitivity status
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IPROS
Time Frame: 2 hours
Immediate pressor response
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mulungushi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPROS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data set and manuscripts published

IPD Sharing Time Frame

2025

IPD Sharing Access Criteria

email

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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