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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04580329
Other study ID # NMES
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date November 30, 2020

Study information

Verified date October 2020
Source Assiut University
Contact Ahmed T Ahmed, A professor
Phone 01062716629
Email talaat83@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 30, 2020
Est. primary completion date November 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Egypt Ahmed Talaat Ahmed Assiut
Egypt Ahmed Talaat Ahmed Assiut

Sponsors (1)

Lead Sponsor Collaborator
Ahmed talaat ahmed aly

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary renal function change serum creatinine level will be assessed and it will show improvement for 7 days
Primary renal blood flow change urine output will be assessed and it will show improvement for 7 days
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