Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2019-04-08
2020-06-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Liberal Fluid Management
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
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients over 18 years old
3. ASA 1-2-3 patients
Exclusion Criteria
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
18 Years
90 Years
FEMALE
No
Sponsors
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Bakirkoy Dr. Sadi Konuk Research and Training Hospital
OTHER_GOV
Responsible Party
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Güneş Özlem Yıldız
principal investigator
Principal Investigators
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güneş özlem yildiz
Role: PRINCIPAL_INVESTIGATOR
bakırköy Dr. Sadi Konuk Education hospital
Locations
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Bakırköy Dr sadi konuk Education hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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2019/152
Identifier Type: -
Identifier Source: org_study_id
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