The Effect of Neuromuscular Electrical Stimulation (NMES) on the Renal Function and Renal Blood Flow (NMES)

October 12, 2020 updated by: Ahmed talaat ahmed aly

The Effect of Neuromuscular Electrical Stimulation (NMES) on the Renal Function and Renal Blood Flow for Patients With Pregnancy Related- Acute Kidney Injury

A randomized prospective controlled study aims to evaluate the effect of neuromuscular electrical stimulation on the renal function and renal blood flow of post partum women with acute kidney injury.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
      • Assiut, Egypt, 71111
        • Recruiting
        • Ahmed Talaat Ahmed

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients aged 18 or old and hemodynamically stable.
  • Post-partum women who developed AKI.

Exclusion Criteria:

  • Pregnant women .
  • Patients who required any emergency or elective surgery during the study; those who presented acute heart or lung disease, skin rashes, tumors, infections, diabetes mellitus or hypoesthesia in the region that the neuromuscular electrical stimulation would be applied.
  • Patients with a Pacemaker.
  • Epileptic Patients.
  • Patients with recent effects of stroke (less than 3 months).
  • Uncontrolled hypertension (systolic blood pressure > 230 mm Hg and diastolic blood pressure > 120 mm Hg).

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: control group
Procedure: routine hospital care without NMES
routine hospital care include all the routine intervention done for post partum women with AKI including fluid resuscitation, diuretics, hemodialysis
Experimental: NMES group
Procedure: neuromuscular electrical stimulation (NMES) in addition to routine hospital care

Patients in the NMES group will receive NMES sessions as the electrodes will be placed around the bilateral femoral quadriceps muscles and at the site of renal arteries.

NMES(>100 Hz, 50-80 μ sec) will be performed for 55 min including 5 minutes for warm up and 5 minutes for recovery .

The intensity of electrical stimulation will be adjusted to suit the comfort level of each individual patient without producing discomfort or pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
renal function change
Time Frame: for 7 days
serum creatinine level will be assessed and it will show improvement
for 7 days
renal blood flow change
Time Frame: for 7 days
urine output will be assessed and it will show improvement
for 7 days

Collaborators and Investigators

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

Sponsor

Ahmed talaat ahmed aly

Investigators

  • Principal Investigator: Ahmed T Ahmed, A professor, Assiut 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 (Anticipated)

October 15, 2020

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMES

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

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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