Renal Function DisorderNCT04069871
Transcutaneous Electrical Nerve Stimulation for Tissues Perfusion
A study testing trans-cutaneous electrical nerve stimulation. in people with Renal Function Disorder and Critical Illness, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to determine the effect of transcutaneous electrical nerve stimulation in mechanically ventilated patients on the lower limb and renal tissue perfusion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Function Disorder, Critical Illness, Critical Illness Myopathy
- What is being tested?
- trans-cutaneous electrical nerve stimulation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2019to 6 Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recently intubated patient.
- Adult and both gender.
- Hemodynamic stability
Who cannot join
- Vascular diseases
- Diabetic patients
- Patients who receive vasoactive drugs
- Patients with varicose vein
- Systemic scoliosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Electrical Nerve Stimulation on Tissue Perfusion for the Critically Ill Patient
The aim of this study is to determine the effect of transcutaneous electrical nerve stimulation in mechanically ventilated patients on the lower limb and renal tissue perfusion.
- Being tested
- trans-cutaneous electrical nerve stimulation., Sham TENS
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-cutaneous electrical nerve stimulation.Device
- Patients assigned to the EMS group received daily EMS sessions of both lower extremities starting from the second day for 5days.
Sham TENSDevice
Patients in the control group will receive sham TENS.
| Study group | Role | What they receive |
|---|---|---|
| TENS | Active comparator | Not described Receives: Device: trans-cutaneous electrical nerve stimulation. |
| Control | Sham comparator | Not described Receives: Device: Sham TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue perfusion of the lower limb.
capillary refill time
Measured: 5 ICU days
Renal perfusion
quantitative assessment of neutrophil gelatinase-associated lipocalin
Measured: 5 ICU days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Oct 2019
- Primary completion6 Oct 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Function DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Samy Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069871
- Sponsor's protocol ID
- TENS
- Status last verified
- Dec 2020
- First submitted
- 23 Aug 2019
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Nerve Stimulation on Tissue Perfusion for the Critically Ill Patient
- ClinicalTrials.gov ID
- NCT04069871
- Acronym / sponsor ID
- TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 28 Aug 2019 (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.
The aim of this study is to determine the effect of transcutaneous electrical nerve stimulation in mechanically ventilated patients on the lower limb and renal tissue perfusion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS | Active comparator | Device: trans-cutaneous electrical nerve stimulation. |
| Control | Sham comparator | Device: Sham TENS |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recently intubated patient.
- Adult and both gender.
- Hemodynamic stability
Key exclusion criteria (5 listed)
- Vascular diseases
- Diabetic patients
- Patients who receive vasoactive drugs
- Patients with varicose vein
- Systemic scoliosis
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 |
|---|---|---|
| trans-cutaneous electrical nerve stimulation.• Patients assigned to the EMS group received daily EMS sessions of both lower extremities starting from the second day for 5days. | Device | TENS |
| Sham TENSPatients in the control group will receive sham TENS. | Device | Control |
Primary outcome
tissue perfusion of the lower limb.
Time frame: 5 ICU days
capillary refill time
Renal perfusion
Time frame: 5 ICU days
quantitative assessment of neutrophil gelatinase-associated lipocalin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trans-cutaneous electrical nerve stimulation. in people with Renal Function Disorder and Critical Illness, run by Assiut University at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tissue perfusion of the lower limb. (time frame: 5 ICU 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 16 Dec 2020.