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Clinical Trials/NCT03970928
NCT03970928
Completed
Not Applicable

Comparison of Conventional Fluid Management With Pleth Variability Index Based Goal-directed Fluid Management in Elective Laparoscopic Hysterectomies.

Kanuni Sultan Suleyman Training and Research Hospital1 site in 1 country100 target enrollmentAugust 2, 2019
ConditionsSurgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Enrollment
100
Locations
1
Primary Endpoint
creatinine (mg/dl)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Fluid management is critical in patients undergoing surgery. Goal-directed fluid management (GDFM) protocols have been shown to decrease the length of hospital stay. In this study, we aimed to compare the effects of conventional fluid management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay.

Detailed Description

Fluid management is critical in patients undergoing surgery. Goal-directed fluid management (GDFM) protocols have been shown to decrease the length of hospital stay in various kinds of surgical procedures. In this study, we aimed to compare the effects of conventional fluid management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay. Patients will be randomized to one of the study arms: group1 (conventional fluid management arm) will receive 0.9 % NaCl at a rate of 4- 8 mL/kg/h, a 250-ml bolus crystalloid/ colloid injection will be administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg.; group 2 (GDFM); group 2 (GDFM group) will receive 0.9 % NaCl at rate of 2 mL/kg/h, a 250-mL bolus crystalloid/colloid injection will be administered when PVI is higher than 13 % over 5 min. In both groups, when MAP is still \< 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus ephedrine will be administered. The groups will be compared concerning postoperative blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay.

Registry
clinicaltrials.gov
Start Date
August 2, 2019
End Date
September 10, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gulseren Yilmaz

Principal Investigator, M.D.

Kanuni Sultan Suleyman Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Must be scheduled for laparoscopic hysterectomy Must be American Society of Anesthesiologists (ASA) class I-II-III

Exclusion Criteria

  • American Society of Anesthesiologists (ASA) class IV BMI \> 40 kg/m2 Non-sinus heart rhythm MAP \<65 mmHg at the onset of anesthesia induction Advanced renal and hepatic impairment Ejection fraction \< 50 % Massive bleeding in the perioperative period

Outcomes

Primary Outcomes

creatinine (mg/dl)

Time Frame: 3 hours after the operation

Difference in serum creatinine levels between the two groups 3 hours after the operation

Study Sites (1)

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