Bakırköy Dr sadi konuk Education hospital
Istanbul, Turkey (Türkiye)
NCT Number: NCT03956901
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.
Looking for future studies?
Notify Me18 year–90 year
Female
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: liberal guided
Time frame: 3-4 hours
total fluid given durin operation
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Other Gov
Peroperative and Postoperative Effects of Goal Directed Fluid Therapy in Gynecological Staging Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06167707
Cardiovascular Diseases, Edema
Tampa, Florida, United States
View Trial DetailsNCT06995144
Cardiovascular Diseases, Chronic Disease
Miami, Florida, United States
View Trial DetailsNCT04914455
Cardiovascular Diseases, Cardiovascular Surgery
Lille, NORD, France
View Trial DetailsNCT05957003
Cardiac Surgery, Edema
Tanta, El Gharbyia, Egypt
View Trial Details