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

Primary Purpose

Renal Injury

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
neuromuscular electrical stimulation (NMES) in addition to routine hospital care
routine hospital care without NMES
Sponsored by
Ahmed talaat ahmed aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Renal Injury focused on measuring neuromuscular electrical stimulation, renal function, renal blood flow, Acute kidney injury

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Ahmed Talaat AhmedRecruiting
  • Ahmed Talaat AhmedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NMES group

control group

Arm Description

Outcomes

Primary Outcome Measures

renal function change
serum creatinine level will be assessed and it will show improvement
renal blood flow change
urine output will be assessed and it will show improvement

Secondary Outcome Measures

Full Information

First Posted
September 30, 2020
Last Updated
October 12, 2020
Sponsor
Ahmed talaat ahmed aly
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1. Study Identification

Unique Protocol Identification Number
NCT04580329
Brief Title
The Effect of Neuromuscular Electrical Stimulation (NMES) on the Renal Function and Renal Blood Flow
Acronym
NMES
Official Title
The Effect of Neuromuscular Electrical Stimulation (NMES) on the Renal Function and Renal Blood Flow for Patients With Pregnancy Related- Acute Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Anticipated)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed talaat ahmed aly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Injury
Keywords
neuromuscular electrical stimulation, renal function, renal blood flow, Acute kidney injury

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMES group
Arm Type
Experimental
Arm Title
control group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
neuromuscular electrical stimulation (NMES) in addition to routine hospital care
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
routine hospital care without NMES
Intervention Description
routine hospital care include all the routine intervention done for post partum women with AKI including fluid resuscitation, diuretics, hemodialysis
Primary Outcome Measure Information:
Title
renal function change
Description
serum creatinine level will be assessed and it will show improvement
Time Frame
for 7 days
Title
renal blood flow change
Description
urine output will be assessed and it will show improvement
Time Frame
for 7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed T Ahmed, A professor
Phone
01062716629
Email
talaat83@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amal A Mohamed
Phone
0102 175 9992
Email
amalabdelnasser28@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed T Ahmed, A professor
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Talaat Ahmed
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed talaat
Phone
01062716629
Facility Name
Ahmed Talaat Ahmed
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed T Ahmed, A professor
Phone
01062716629
Email
talaat83@aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Amal A Mohamed
Phone
0102 175 9992
Email
amalabdelnasser28@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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