Inferior Vena Cava Diameter Dependent Colloid Challenge Versus Routine Crystalloid Strategy Transurethral Resection Prostate

Sponsor

Mansoura University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04131361

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Volume Overload	Other: Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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.

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Jun 15, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Crystalloid -control group:	Other: Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement 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.
Experimental: Colloid- study group:	Other: Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement 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.

Arm

Intervention/Treatment

Active Comparator: Crystalloid -control group:

Other: Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement

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.

Experimental: Colloid- study group:

Other: Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement

Outcome Measures

Primary Outcome Measures

Postoperative serum Na+ (at end of surgery). [just after end of surgery]
venous sample

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Inclusion Criteria:
Patients subjected to transurethral resection of prostate TURP.
ASA I&III.
Age 40-80years old.
Surgical procedure: laser and Bipolar TURP using saline 0,9% irrigation.
Exclusion Criteria:
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.
International Normalized Ratio >1.4
Platelet count <100,000 /mm3.
Preoperative serum creatinine >1.5 mg/dL

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Abd Latif Ghanim, Associate Professor os anesthesia ICU & Pain medicine., Mansoura University

ClinicalTrials.gov Identifier:

NCT04131361

Other Study ID Numbers:

R.19.10.644

First Posted:

Oct 18, 2019

Last Update Posted:

Mar 1, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 1, 2021