Goal Directed Fluid Management , Pvi

NCT03956901 | Completed

• 1 other identifier: 2019/152
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The first objective of this study is to compare the liberal fluid management (LFM) with PVI guided goal-directed fluid management (GDFM) in gynecologic oncologic cases in terms of controlled intraoperative fluid balance, blood lactate levels, hemodynamic parameters, and postoperative serum creatinine levels. 112 patients who are in ASA I-II-lll risk groups included in this prospective study.

Conditions

Fluid Overload

Outcome Measures

Primary Outcomes (1)

• fluid management

  total fluid given durin operation

  3-4 hours

Study Arms (2)

Liberal Fluid Management

EXPERIMENTAL

liberal fluid management: 500 ml bolus crystalloid after 4-8 ml/kg/h infusion during surgery total amount of crystalloid volume of fluid infused during gycnecologcy l surgery fluid infused during whole procedure 4-8 ml/kg/h infusion during surgery If MAP \<65 mmHg or \<30%of basal value, infuse 250 ml cyristaloid/Gelofusine bolus and 5 mcg efedrin If MAP\>65 mmHg no intervention

Other: pvi guided fluid management

pvi guided fluid management

EXPERIMENTAL

GDFM Group: 500 ml bolus crystalloid after 2 ml \\ kg crystalloid infusion to be started If PVI \<13 MAP is \<65 mmHg, continue infusion of fluid, 1-2 µg NE bolus to be entered after 5 min. PVI \<13 MAP\> 65 mmHg to continue fluid infusion If PVI\> 13 MAP \<65 mmHg, 250 ml bolus crystalloid \\ colloid will be given and bolus 1-2 µg NE, If it continues after 5 minutes, liquid and NE doses will be repeated. Liquid treatment will be continued until PVI \<13. PVI\> 13 MAP \<65 mmHg 250 ml bolus fluid to be given, if continued 5 minutes later to be repeated,repetition of fluid will continue until PVl \<13.

Other: pvi guided fluid management

Interventions

pvi guided fluid management OTHER

GDFM Group: 500 ml bolus crystalloid after 2 ml \\ kg crystalloid infusion to be started If PVI \<13 MAP is \<65 mmHg, continue infusion of fluid, 1-2 µg NE bolus to be entered after 5 min. PVI \<13 MAP\> 65 mmHg to continue fluid infusion If PVI\> 13 MAP \<65 mmHg, 250 ml bolus crystalloid \\ colloid will be given and bolus 1-2 µg NE, If it continues after 5 minutes, liquid and NE doses will be repeated. Liquid treatment will be continued until PVI \<13. PVI\> 13 MAP \<65 mmHg 250 ml bolus fluid to be given, if continued 5 minutes later to be repeated,repetition of fluid will continue until PVl \<13.

Also known as: liberal guided

Liberal Fluid Management; pvi guided fluid management

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gynecological oncologic cases
• Patients over 18 years old
• ASA 1-2-3 patients

You may not qualify if:

• Patients with peripheral arterial disease
• Patients with non-sinus rhythm, arrhythmia, atrial fibrillation
• Patients with entry MAP \<65 mmHg
• Patients with advanced renal and hepatic impairment
• Mental retarded and non-cooperative patients
• Patients with advanced heart failure, EF \<30%
• Patients have massive bleeding in the perioperative period, need for massive transfusion
• Patients have acute pulmonary pathology
• Patients with anaphylaxis who developed a blood product reaction
• Patients who do not allow a tidal volume of 8ml / kg in a mechanical ventilator

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakırköy Dr sadi konuk Education hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• güneş özlem yildiz

  bakırköy Dr. Sadi Konuk Education hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: April 8, 2019
• Primary Completion: May 8, 2019
• Study Completion: June 20, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-05

Locations

TU (1)