Goal Directed Fluid Management , Pvi

Fluid Overload Clinical Trial

Official title:

Peroperative and Postoperative Effects of Goal Directed Fluid Therapy in Gynecological Staging Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956901
• Other study ID #: 2019/152
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: June 20, 2020

Study information

• Verified date: May 2020
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objectives: The first objective of the investigators's study was to compare the liberal fluid management (LFM) with PVI guided goal-directed fluid management (GDFM) in terms of controlled intraoperative fluid volume, surgical end-point fluid balance, blood lactate and serum creatinine levels.

The investigators's secondary purpose was to compare the effects of different fluid regimens on the postoperative kidney injury and the duration of hospital stay.

Methods: The study included 112 American Society of Anesthesiologists (ASA) grade I ,ll and lll patients, aged above 18 and undergoing elective gynecologic oncologic case . After premedication with 0.03 mg /kg i.v. midazolam, all patients were started an i.v. infusion of 500 mL 0.9 % NaCl until the end of anesthesia induction.

After the anesthesia induction, while 0.9 % NaCl at rate of 2 mL/kg/h was infused in PVI- guided GDFM group, a 250-mL bolus cyristalloid/kolloid injection was administered when PVI was higher than 13 % over 5 min. While 0.9 % NaCl at rate of 4- 8 mL/kg/h was infused in LFM group, a 250-ml bolus cyristalloid/ kolloid injection was administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg. In both groups, when MAP was still < 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus ephedrine was administered. The data collected during intraoperative period, such as heart rate, MAP, arterial blood gas samples (Ph, arterial oxygen pressure (PaO2), arterial carbon dioxide pressure (PaCO2), HCO3 level, hemoglobin, blood lactate level) were recorded. Hemoglobin, Na, K, Cl, serum creatinine, blood lactate and serum albumin scores were measured preoperatively, and up to 24 hours postoperative.

In the first 24 hours after surgery, urine output, need for blood transfusion ,lokositoz,fever,stay in icu and length of hospital stay were recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 20, 2020
• Est. primary completion date: May 8, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Gynecological oncologic cases

2. Patients over 18 years old

3. ASA 1-2-3 patients

Exclusion Criteria:

1. Patients with peripheral arterial disease

2. Patients with non-sinus rhythm, arrhythmia, atrial fibrillation

3. Patients with entry MAP <65 mmHg

4. Patients with advanced renal and hepatic impairment

5. Mental retarded and non-cooperative patients

6. Patients with advanced heart failure, EF <30%

7. Patients have massive bleeding in the perioperative period, need for massive transfusion

8. Patients have acute pulmonary pathology

9. Patients with anaphylaxis who developed a blood product reaction

10. Patients who do not allow a tidal volume of 8ml / kg in a mechanical ventilator

Related Conditions & MeSH terms

• Fluid Overload

Intervention

Other:
• pvi guided fluid management
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.

Locations

Country	Name	City	State
Turkey	Bakirköy Dr sadi konuk Education hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fluid management	total fluid given durin operation	3-4 hours