The Effect of Neuromuscular Electrical Stimulation (NMES) on the Renal Function and Renal Blood Flow
NMES
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
October 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedOctober 14, 2020
October 1, 2020
17 days
September 30, 2020
October 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
renal function change
serum creatinine level will be assessed and it will show improvement
for 7 days
renal blood flow change
urine output will be assessed and it will show improvement
for 7 days
Study Arms (2)
NMES group
EXPERIMENTALcontrol group
EXPERIMENTALInterventions
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.
routine hospital care include all the routine intervention done for post partum women with AKI including fluid resuscitation, diuretics, hemodialysis
Eligibility Criteria
You may qualify if:
- Patients aged 18 or old and hemodynamically stable.
- Post-partum women who developed AKI.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ahmed Talaat Ahmed
Asyut, 71111, Egypt
Ahmed Talaat Ahmed
Asyut, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed T Ahmed, A professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 8, 2020
Study Start
October 15, 2020
Primary Completion
November 1, 2020
Study Completion
November 30, 2020
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share