Renal InjuryNMESNCT04580329
The Effect of Neuromuscular Electrical Stimulation (NMES) on the Renal Function and Renal Blood Flow
A study testing neuromuscular electrical stimulation (NMES) in addition to routine hospital care and routine hospital care without NMES in people with Renal Injury, run by Ahmed talaat ahmed aly at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Renal Injury
- What is being tested?
- neuromuscular electrical stimulation (NMES) in addition to routine hospital care and routine hospital care without NMES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Oct 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 or old and hemodynamically stable.
- Post-partum women who developed AKI.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Ahmed Talaat Ahmed
Asyut, 71111
ahmed talaat, 01062716629
- Recruiting
Ahmed Talaat Ahmed
Asyut
Ahmed T Ahmed, A professor, 01062716629, talaat83@aun.edu.eg
Amal A Mohamed, 0102 175 9992, amalabdelnasser28@gmail.com
About this study
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
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.
- Conditions
- Renal Injury
- Being tested
- neuromuscular electrical stimulation (NMES) in addition to routine hospital care, routine hospital care without NMES
- Keywords
- neuromuscular electrical stimulation, renal function, renal blood flow, Acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular electrical stimulation (NMES) in addition to routine hospital careProcedure or surgery
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 NMESProcedure or surgery
routine hospital care include all the routine intervention done for post partum women with AKI including fluid resuscitation, diuretics, hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| NMES group | Experimental | Not described Receives: Procedure: neuromuscular electrical stimulation (NMES) in addition to routine hospital care |
| control group | Experimental | Not described Receives: Procedure: routine hospital care without NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function change
serum creatinine level will be assessed and it will show improvement
Measured: for 7 days
renal blood flow change
urine output will be assessed and it will show improvement
Measured: for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed talaat ahmed aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed talaat ahmed aly, Assiut University
- Investigators
- Ahmed T Ahmed, A professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580329
- Sponsor's protocol ID
- NMES
- Acronym
- NMES
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04580329
- Acronym / sponsor ID
- NMES / NMES
- Conditions
- Renal Injury
- Keywords
- neuromuscular electrical stimulation, renal function, renal blood flow, Acute kidney injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahmed talaat ahmed alyUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES group | Experimental | Procedure: neuromuscular electrical stimulation (NMES) in addition to routine hospital care |
| control group | Experimental | Procedure: routine hospital care without NMES |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged 18 or old and hemodynamically stable.
- Post-partum women who developed AKI.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscular electrical stimulation (NMES) in addition to routine hospital carePatients 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. | Procedure or surgery | NMES group |
| routine hospital care without NMESroutine hospital care include all the routine intervention done for post partum women with AKI including fluid resuscitation, diuretics, hemodialysis | Procedure or surgery | control group |
Primary outcome
renal function change
Time frame: for 7 days
serum creatinine level will be assessed and it will show improvement
renal blood flow change
Time frame: for 7 days
urine output will be assessed and it will show improvement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed T Ahmed, A professor principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular electrical stimulation (NMES) in addition to routine hospital care and routine hospital care without NMES in people with Renal Injury, run by Ahmed talaat ahmed aly at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed T Ahmed, A professor (01062716629, talaat83@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal function change (time frame: for 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.