Transurethral Resection of Prostate SyndromePhase 4NCT03324477
The Hemodynamic Effects of Hypertonic Saline Preload Versus Coload Measured by Non-invasive Cardiometry in Patients Undergoing TURP Surgery
A Phase 4 study testing hypertonic saline 3% in people with Transurethral Resection of Prostate Syndrome, run by Nazmy Edward Seif at 1 site in Egypt.
Trial summary
This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Transurethral Resection of Prostate Syndrome
- What is being tested?
- hypertonic saline 3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 30 Dec 2023
- Phase
- Phase 4
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I - III.
Who cannot join
- Patient refusal.
- Patient in whom spinal anesthesia is absolutely contraindicated.
- Known sensitivity to local anesthetics.
- Preoperative electrolyte imbalance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiometrically Evaluated NaCl 3% Coload Versus Preload for TURP. A Randomized Controlled Trial.
This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.
Read the detailed description
Benign prostatic hyperplasia is common in elderly males, and this group of patients is commonly associated with different comorbidities especially of the cardiovascular system , this make them at risk of many intraoperative complications. The associated adverse effects arising in both the cardiovascular and nervous systems are known as transurethral resection (TUR) syndrome.Therefore TURP patients need meticulous monitoring of hemodynamics and fluid therapy.
This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.
100 ASA physical status I-III male patients scheduled to electively undergo transurethral resection of the prostate under spinal subarachnoid block were included in this study
Preload group (Group P):
50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula over 15-20 min before the induction of spinal anaesthesia.
Co-load group (Group C):
50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula at the maximal possible rate at the time of identification of C.S.F .
- Being tested
- hypertonic saline 3%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic saline 3%Drug
Also called hypertonic saline
hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma
| Study group | Role | What they receive |
|---|---|---|
| preload group | Experimental | Patients will receive 4 ml/kg of hypertonic saline 3% via G14 cannula over 15-20 min before the induction of spinal anaesthesia. Receives: Drug: hypertonic saline 3% |
| coload group | Experimental | Patients will receive 4 ml/kg of hypertonic saline 3% via G14cannula at the maximal possible rate at the time of identification of C.S.F . Receives: Drug: hypertonic saline 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
systolic blood pressure is measured by mmHg
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Nov 2017
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transurethral Resection of Prostate SyndromeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Nazmy E Seif, MD, Principal investigator, Cairo UniversityManal M Elgohary, MD, Principal investigator, Cairo UniversityManar M Elkholy, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324477
- Sponsor's protocol ID
- 11-2017
- Status last verified
- Feb 2025
- First submitted
- 22 Oct 2017
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometrically Evaluated NaCl 3% Coload Versus Preload for TURP. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03324477
- Acronym / sponsor ID
- 11-2017
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nazmy Edward SeifUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 27 Oct 2017 (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.
This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.
Detailed description
Benign prostatic hyperplasia is common in elderly males, and this group of patients is commonly associated with different comorbidities especially of the cardiovascular system , this make them at risk of many intraoperative complications. The associated adverse effects arising in both the cardiovascular and nervous systems are known as transurethral resection (TUR) syndrome.Therefore TURP patients need meticulous monitoring of hemodynamics and fluid therapy.
This study is designed to investigate the relevance of the timing of hypertonic saline administration either as a preload or as a coload on hemodynamic parameters in patients undergoing TURP surgeries.
100 ASA physical status I-III male patients scheduled to electively undergo transurethral resection of the prostate under spinal subarachnoid block were included in this study
Preload group (Group P):
50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula over 15-20 min before the induction of spinal anaesthesia.
Co-load group (Group C):
50 Patients will receive 4 ml/kg of hypertonic saline (NaCL3%) via G14 cannula at the maximal possible rate at the time of identification of C.S.F .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preload group | Experimental | Drug: hypertonic saline 3%Patients will receive 4 ml/kg of hypertonic saline 3% via G14 cannula over 15-20 min before the induction of spinal anaesthesia. |
| coload group | Experimental | Drug: hypertonic saline 3%Patients will receive 4 ml/kg of hypertonic saline 3% via G14cannula at the maximal possible rate at the time of identification of C.S.F . |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I - III.
Key exclusion criteria (4 listed)
- Patient refusal.
- Patient in whom spinal anesthesia is absolutely contraindicated.
- Known sensitivity to local anesthetics.
- Preoperative electrolyte imbalance.
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 |
|---|---|---|
| hypertonic saline 3%Also: hypertonic salinehypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma | Drug | coload group, preload group |
Primary outcome
systolic blood pressure
Time frame: two hours
systolic blood pressure is measured by mmHg
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 12 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Lung Ultrasound Versus Inferior Vena Cava Collapsibility Index for Early Prediction of Volume Overload During Transurethral Resection of Prostate
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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.
Nazmy E Seif, MD principal investigator
Cairo University
Manal M Elgohary, MD principal investigator
Cairo University
Manar M Elkholy, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hypertonic saline 3% in people with Transurethral Resection of Prostate Syndrome, run by Nazmy Edward Seif 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 1 inclusion and 4 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 12 Feb 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
systolic blood pressure (time frame: two hours). 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 12 Feb 2025.