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Goal Directed Fluid Management , Pvi

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ClinicalTrials.gov Identifier: NCT03956901
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Güneş Özlem Yıldız, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE April 8, 2019
Estimated Primary Completion Date September 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
fluid management [ Time Frame: 3-4 hours ]
total fluid given durin operation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03956901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Goal Directed Fluid Management , Pvi
Official Title  ICMJE Peroperative and Postoperative Effects of Goal Directed Fluid Therapy in Gynecological Staging Surgery
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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Fluid Overload
Intervention  ICMJE 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.

Other Name: liberal guided
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Other: pvi guided fluid management
  • Experimental: 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.

    Intervention: Other: pvi guided fluid management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2019)
112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date September 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: gunes ozlem MD yildiz, specialist +905303603749 drgunesim@hotmail.com
Contact: duygu md akyol, specialist 05447616034 duygu.aygun@saglik.gov.tr
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03956901
Other Study ID Numbers  ICMJE 2019/152
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Güneş Özlem Yıldız, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study Sponsor  ICMJE Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: güneş özlem yildiz bakırköy Dr. Sadi Konuk Education hospital
PRS Account Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP