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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03339895
Enrollment
70
Registered
2017-11-13
Start date
2016-01-01
Completion date
2017-01-25
Last updated
2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Overload

Keywords

COLORECTAL SURGERY, PVI GUIDED FLUID MANAGEMENT, GOAL DIRECTED THERAPY

Brief summary

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.

Detailed 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.

Interventions

OTHERpvı-guided

pvı- guided total amount of crystalloid volume of fluid infused during colorectal surgery pvı-guided(according to pvi value) fluid infused during whole procedure 2 ml/kg/h infusion during surgery If PVI value \<%13 and if MAP\>65mmHg continue with 2 ml/kg/h cristalloid infusion If PVI value \<%13 and if MAP\>65mmHg 5 mcg efedrin intravenous bolus till MAP\>65 mmHg If PVI value \>%13 and MAP\>65 mmHg infuse 250 ml Gelofusine bolus up to PVI value lowers to %13 every 5 minute If PVI value \>%13 and MAP \<65 mmHg infuse 250 ml Gelofusine bolus and 5 mcg efedrin intravenous up to PVI value lowers to %13

OTHERtraditional-guided

traditional-guided total amount of crystalloid volume of fluid infused during colorectal surgery traditional-guided 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 Gelofusine bolus and 5 mcg efedrin If MAP\>65 mmHg no intervention

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* \> 18 age * elective colorectal suregry * ASA 1-2

Exclusion criteria

* Chronic renal disease * Ejection fraction \< 30 * arthmia

Design outcomes

Primary

MeasureTime frameDescription
FLUID MANAGEMENTtwo hourstotal fluid given during colorectal surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026