Electric Cardiometry-Guided Standard Versus Restricted Fluid Therapy In Robotic Prostaectomy

NCT07626151 | Recruiting

• 1 other identifier: ECGSVRFTRP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery; Prostate Cancer; Lactate Blood Increase; Fluid Overload

Keywords

Robotic; Prostatectomy; Sugery; Anesthesia; Fluid; Electric Cardiometry; Tissue Perfusion

Outcome Measures

Primary Outcomes (1)

• Serum Lactate level difference

  Serum Lactate level difference between pre-operative (baseline) value and post-operative (recovery) value in mmol/L

  24 hours

Study Arms (2)

Liberal Group

ACTIVE COMPARATOR

Liberal Fluid Therapy Group

Procedure: Liberal Fluid Therapy

Restricted Group

ACTIVE COMPARATOR

Restricted Fluid Therapy Group

Procedure: Restricted Fluid Therapy

Interventions

Liberal Fluid Therapy PROCEDURE

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 dose 0.01mcg/kg/min if MAP is below 65 mmHg.

Liberal Group

Restricted Fluid Therapy PROCEDURE

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 dose 0.01mcg/kg/min if MAP is below 65 mmHg.

Restricted Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patient undergoing robotic assisted prostatectomy
• ASA I-III

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nazmy Edward Seif: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Edema; Hyperlactatemia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ashgan R Aly, M.D.

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  STUDY CHAIR

• Nazmy S Mikhael, M.D.

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  PRINCIPAL INVESTIGATOR

• Mohamed M Mohamed, M.Sc.

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M Mohamed, M.Sc.

CONTACT

+20 111 8370641; mandamembo0@gmail.com

Nazmy S Mikhael, M.D.

CONTACT

+20122 7400808; drnazmyseif@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

EG (1)