Electric Cardiometry-Guided Standard Versus Restricted Fluid Therapy In Robotic Prostaectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liberal Fluid Therapy, Restricted Fluid Therapy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Surgery, Fluid Overload, Lactate Blood Increase. Basic parameters: 40 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect Of Standard Versus Restricted Fluid Therapy Guided By Electric Cardiometry On Tissue Perfuison In Robotic Prostaectomy: A Randomized Controlled Study
Overview
Fluid therapy during surgery is an important factor that is related to long term mortality and morbidity and it's directly related to tissue perfusion as well. The main target in any surgery is what is the optimum fluid therapy to maintain the tissue perfusion and the precise balance between hazardous effects of hypervolemia that may cause delayed wound healing due to surgical anastomosis disruption or being hypovolemic that may cause tissue ischemia as acute kidney injury. Fluid management guidance changed from static methods like central venous pressure into dynamic methods like pulse pressure variation (PPV) and stroke volume variation (SVV), which are now the most famous dynamic measures. Electrical cardiometry is a non-invasive cardiac output monitor which uses electrical cardiometry, now a commonly used device, to measure SVV which can be used to guide fluid therapy during surgeries. Now robotic assisted surgery is a common method in preforming many surgeries especially urological, since it's associated with numerous desirable outcomes including shorter post-operative stay and faster return to preoperative function. With considerations related to severe Trendelenburg position and increased intra-abdominal pressure due to pneumo-peritoneum, robotic assisted surgeries are associated with many challenges in anesthesia especially the fluid therapy. Fluid therapy in robotic surgeries is an area with growing research focus that need further exploration while there are established guidelines for fluid management in traditional surgeries, the optimal protocols for robotic surgeries are less well defined, needing more research. We aim at this study to investigate the impact of liberal versus restricted fluid intake on the tissue perfusion reflected by serum lactate \& creatinine clearance, while guiding therapy through electrical cardiometry, to reach optimum fluid protocol in prostatic robotic surgeries.
Interventions
- Procedure Liberal Fluid Therapy
Patients will receive 6 ml/kg/hour of lactated ringer for maintenance in addition to fasting hours compensation (2 ml/kg for each fasting hour, given as 50% in the first hour of surgery, then 25% during the second \& third hours). An additional bolus of 200 ml Lactated Ringer will be given if MAP is below 65 mmHg. In case of persistent hypotension despite proper fluid rescuistation, 10 mg of Ephedrine will be administered; if no response is achieved, norepinerhine infusion will start at initial - Procedure Restricted Fluid Therapy
Patients will receive 2 ml/kg as fluid bolus then 2 ml/kg/hour for maintenance, aiming at a target SVV less than 13 %. Patients with SVV ≥ 13% will be considered fluid responder and will receive a fluid bolus of 200 ml Ringer Lactated Ringer over 10 minutes.The fluid bolus will be repeated until the SVV is less than 13%. In case of persistent hypotension (MAP less than 65mmHg), 10 mg of Ephedrine will be administered; if no response is achieved, norepinerhine infusion will be started at intial d
Primary outcome measures
- Serum Lactate level difference [Time frame: 24 hours]
Eligibility criteria
Inclusion criteria
- Male patient undergoing robotic assisted prostatectomy
- ASA I-III
Exclusion criteria
- ASA score more than III
- BMI more than 40
- Severe renal disease (GFR between 15 and 29)
- Previous renal surgery.
- Decompensated cardiac disease (NYHA class 3 or 4)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Egypt · 1 center
- Cairo University Hospitals — Cairo
Identifiers
NCT: NCT07626151 · ECGSVRFTRP