Goal-directed Fluid Management Versus Conventional Fluid Management in Laparoscopic Hysterectomy

NCT03970928 | Completed

• 1 other identifier: Gulseren2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Fluid management is critical in patients undergoing surgery. Goal-directed fluid management (GDFM) protocols have been shown to decrease the length of hospital stay. In this study, we aimed to compare the effects of conventional fluid management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• creatinine (mg/dl)

  Difference in serum creatinine levels between the two groups 3 hours after the operation

  3 hours after the operation

Study Arms (2)

goal-directed fluid management (GDFM)

ACTIVE COMPARATOR

A pulse oximetry probe will be connected to the fourth finger of the hand in which there was not an arterial catheter in all patients and it will be wrapped so that it would not be affected by the external light. The pulse oximeter will then be connected to a monitor including the PVI software which automatically and continuously calculates the respiratory variations in the photoplethysmogram from data collected noninvasively via a pulse oximetry sensor. 0.9 % NaCl at a rate of 2 mL/kg/h will be infused in PVI- guided GDFM group, a 250-mL bolus crystalloid/colloid injection will be administered when PVI was higher than 13 % over 5 min.

Device: PVI

Conventional fluid management group (CFMG)

NO INTERVENTION

This group will receive conventional fluid management described as follows: 0.9 % NaCl at a rate of 4- 8 mL/kg/h will be infused in CFGM group, a 250-ml bolus crystalloid/ colloid injection will be administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg.

Interventions

PVI DEVICE

A pulse oximetry probe which transfers data to the monitor with software able to calculate PVI data. The monitor automatically and continuously calculates the respiratory variations in the photoplethysmogram from data collected noninvasively via a pulse oximetry sensor.

goal-directed fluid management (GDFM)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be scheduled for laparoscopic hysterectomy Must be American Society of Anesthesiologists (ASA) class I-II-III

You may not qualify if:

• \- American Society of Anesthesiologists (ASA) class IV BMI \> 40 kg/m2 Non-sinus heart rhythm MAP \<65 mmHg at the onset of anesthesia induction Advanced renal and hepatic impairment Ejection fraction \< 50 % Massive bleeding in the perioperative period

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, 34005, Turkey (Türkiye)

Location

Study Officials

• Gulseren Yilmaz, MD

  Kanuni Sultan Suleyman Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: June 3, 2019
• Study Start: August 2, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 10, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)