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Comparison of PVI-guided Fluid Management With Traditional Fluid Management in Colorectal Surgery

K

Kocaeli University

Status

Completed

Conditions

Fluid Overload

Treatments

Other: traditional-guided
Other: pvı-guided

Study type

Interventional

Funder types

Other

Identifiers

NCT03339895
KOU KAEK 2015/99

Details and patient eligibility

About

The first objective of this study was to compare the traditional fluid management (TFM) 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. ASA I-II 70 patients included in this prospective study.

Full description

Objectives: The first objective of our study was to compare the traditional fluid management (TFM) 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. Our secondary purpose was to compare the effects of different fluid regimens on the return of bowel function and the duration of hospital stay. Methods: The study included 70 American Society of Anesthesiologists (ASA) grade I and II patients, aged above 18 and undergoing elective colorectal surgery. 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 gelatin injection (Gelofusine®, Barun) 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 TFM group, a 250-ml bolus gelatin injection (Gelofusine®, Barun) 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, oliguria (<0.5 ml / kg urine output), need for blood transfusion and the time of first bowel movement (depending on the days after surgery), length of hospital stay were recorded.

Enrollment

70 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • > 18 age
  • elective colorectal suregry
  • ASA 1-2

Exclusion criteria

  • Chronic renal disease
  • Ejection fraction < 30
  • arthmia

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

70 participants in 2 patient groups

pvı-guided
Experimental group
Description:
pvı-guided(according to pvi value) fluid infused during whole procedure 2 ml/kg/h infusion during surgery
Treatment:
Other: pvı-guided
traditional-guided
Experimental group
Description:
4-8 ml/kg/h infusion during surgery
Treatment:
Other: traditional-guided

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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