Volume OverloadNCT04131361
Inferior Vena Cava Diameter Dependent Colloid Challenge Versus Routine Crystalloid Strategy Transurethral Resection Prostate
A study testing Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement in people with Volume Overload, run by Mansoura University at 1 site in Egypt.
Trial summary
Background: Intravenous fluid replacement during transurethral resection of the prostate is still unclear. Ultrasonography of the inferior vena cava (IVC) has been recently used to assess the volume status and predict fluid responsiveness. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Volume Overload
- What is being tested?
- Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 30 Dec 2022
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients subjected to transurethral resection of prostate TURP.
- ASA I\&II
- Age 40-80years old. prostate size 45-100
- Surgical procedure: laser and Bipolar TURP using saline 0,9% irrigation.
Who cannot join
- Height <150 cm.
- Weight <60 kg.
- Body mass index ≥45 kg/m2.
- Contraindications to spinal anesthesia (increased intracranial pressure or local skin infection).
- Uncontrolled; Diabetes mellitus, cardiovascular failure, cerebrovascular uncontrolled deficite, or other renal disease.
- Hemoglobin <10 gm/dL.
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- International Normalized Ratio >1.4
- Platelet count <100,000 /mm3.
- Preoperative serum creatinine >1.5 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Inferior Vena Cava Diameter Dependent Colloid Challenge Versus Routine Crystalloid Strategy Fluid Replacement in Transurethral Resection Prostate (TURP) Under Spinal Anesthesia; A Prospective Randomized Controlled Study.
Background: Intravenous fluid replacement during transurethral resection of the prostate is still unclear. Ultrasonography of the inferior vena cava (IVC) has been recently used to assess the volume status and predict fluid responsiveness. In this double-blind, randomized controlled study, we will assess the IVC at baseline and at subsequent time points after spinal anesthesia, and according to IVC diameter will give the replacement challenge colloid. Potential problems during TURP are mostly due to either fluid overload or bleeding: Intraoperative TURP syndrome, Hemorrhage, Myocardial ischemia, Hypothermia, Prostatic capsular perforation, Bladder or urethral perforation. Postoperative TURP syndrome, myocardial ischemia/infarction, Postoperative cognitive impairment. Study Hypothesis: Strict colloid volume optimization using US-guided IVC diameter calculation aiming decrease the total IV fluid volume and accommodate the transurethral inevitable absorption of currently used irrigation crystalloid fluid (Nacl0.9%) that accidentally absorbed and change it from a circulatory overload to a complementary part of the replacement IV fluids preventing fluid overload and TURP syndrome. Aim of the work: To reduce Intraoperative and postoperative fluid overload during TURP surgery with hemodynamic stability relaying up on US-guided IVC diameter dependent Strict IV Colloid replacement volume optimization. Methods: A prospective randomized controlled trial on ASAI-III male patient aged 40-80 years old subjected to transurethral endoscopic resection of the prostate (TURP) surgery. Then patients will be divided into 2 groups according to the IV infusion fluid type as follow: Crystalloid -control group: (preload plus continuous IO Ringer acetate crystalloid 4/2/1 rule infusion) according to the usual 4/2/1 rule. Not guided by IVC diameter but IVC diameter will be calculated using the US and recorded at baseline just after spinal anesthesia and then every 30 minutes till the end of surgery. Loop Diuretic (Furosemide) will be given according to the maximum diameter of the IVC as follow; 10mg if IVC>2.5Cm. Colloid- study group: (preload plus colloid challenge only); Fluid challenge boluses of 250 mL (over 5 minutes using a pressurizer) 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) if the IVC<1.7(higher limit of normal) will be given guided by IVC diameter at baseline just after spinal anesthesia and then every 30 minutes till the end of surgery.
- Conditions
- Volume Overload
- Being tested
- Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacementOther
The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region.
| Study group | Role | What they receive |
|---|---|---|
| Crystalloid -control group: | Active comparator | Not described Receives: Other: Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement |
| Colloid- study group: | Experimental | Not described Receives: Other: Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
total iv fluids
Measured: just after end of surgery
Secondary outcomes (6)
serum Na at end of surgery
Measured: just after end of surgery
serum K at end of surgery
Measured: just after end of surgery
ximum and minimum IVC diameter
Measured: serial during surgery
IVC-CI
Measured: serial during surgery
Incidence of bradycardia
Measured: serial during surgery
Incidence of hypo-tension
Measured: serial during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Oct 2022
- Primary completion25 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volume OverloadStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd Latif Ghanim, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131361
- Sponsor's protocol ID
- R.19.10.644
- Status last verified
- Jun 2023
- First submitted
- 12 Oct 2019
- Last updated
- 12 Jun 2023
- 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 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Inferior Vena Cava Diameter Dependent Colloid Challenge Versus Routine Crystalloid Strategy Fluid Replacement in Transurethral Resection Prostate (TURP) Under Spinal Anesthesia; A Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04131361
- Acronym / sponsor ID
- R.19.10.644
- Conditions
- Volume Overload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Oct 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.
Background: Intravenous fluid replacement during transurethral resection of the prostate is still unclear. Ultrasonography of the inferior vena cava (IVC) has been recently used to assess the volume status and predict fluid responsiveness. In this double-blind, randomized controlled study, we will assess the IVC at baseline and at subsequent time points after spinal anesthesia, and according to IVC diameter will give the replacement challenge colloid. Potential problems during TURP are mostly due to either fluid overload or bleeding: Intraoperative TURP syndrome, Hemorrhage, Myocardial ischemia, Hypothermia, Prostatic capsular perforation, Bladder or urethral perforation. Postoperative TURP syndrome, myocardial ischemia/infarction, Postoperative cognitive impairment. Study Hypothesis: Strict colloid volume optimization using US-guided IVC diameter calculation aiming decrease the total IV fluid volume and accommodate the transurethral inevitable absorption of currently used irrigation crystalloid fluid (Nacl0.9%) that accidentally absorbed and change it from a circulatory overload to a complementary part of the replacement IV fluids preventing fluid overload and TURP syndrome. Aim of the work: To reduce Intraoperative and postoperative fluid overload during TURP surgery with hemodynamic stability relaying up on US-guided IVC diameter dependent Strict IV Colloid replacement volume optimization. Methods: A prospective randomized controlled trial on ASAI-III male patient aged 40-80 years old subjected to transurethral endoscopic resection of the prostate (TURP) surgery. Then patients will be divided into 2 groups according to the IV infusion fluid type as follow: Crystalloid -control group: (preload plus continuous IO Ringer acetate crystalloid 4/2/1 rule infusion) according to the usual 4/2/1 rule. Not guided by IVC diameter but IVC diameter will be calculated using the US and recorded at baseline just after spinal anesthesia and then every 30 minutes till the end of surgery. Loop Diuretic (Furosemide) will be given according to the maximum diameter of the IVC as follow; 10mg if IVC>2.5Cm. Colloid- study group: (preload plus colloid challenge only); Fluid challenge boluses of 250 mL (over 5 minutes using a pressurizer) 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) if the IVC<1.7(higher limit of normal) will be given guided by IVC diameter at baseline just after spinal anesthesia and then every 30 minutes till the end of surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystalloid -control group: | Active comparator | Other: Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement |
| Colloid- study group: | Experimental | Other: Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (9 listed)
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 |
|---|---|---|
| Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacementThe inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region. | Other | Colloid- study group:, Crystalloid -control group: |
Primary outcome
total iv fluids
Time frame: just after end of surgery
6 secondary outcomes
serum Na at end of surgery
Time frame: just after end of surgery
serum K at end of surgery
Time frame: just after end of surgery
ximum and minimum IVC diameter
Time frame: serial during surgery
IVC-CI
Time frame: serial during surgery
Incidence of bradycardia
Time frame: serial during surgery
Incidence of hypo-tension
Time frame: serial during surgery
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 Jun 2023.
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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 Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement in people with Volume Overload, run by Mansoura 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 4 inclusion and 9 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 Jun 2023. 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.
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?
total iv fluids (time frame: just after end of surgery). 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 Jun 2023.