NCT03339895

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 13, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

January 30, 2017

Last Update Submit

November 7, 2017

Conditions

Fluid Overload

Keywords

COLORECTAL SURGERYPVI GUIDED FLUID MANAGEMENTGOAL DIRECTED THERAPY

Outcome Measures

Primary Outcomes (1)

  • FLUID MANAGEMENT

    total fluid given during colorectal surgery

    two hours

Study Arms (2)

pvı-guided

EXPERIMENTAL

pvı-guided(according to pvi value) fluid infused during whole procedure 2 ml/kg/h infusion during surgery

Other: pvı-guided

traditional-guided

EXPERIMENTAL

4-8 ml/kg/h infusion during surgery

Other: traditional-guided

Interventions

pvı-guidedOTHER

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

pvı-guided
traditional-guidedOTHER

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

traditional-guided

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sevim Cesur, MD

    Specialist

    PRINCIPAL INVESTIGATOR

  • Tülay Hoşten, MD

    Specialist

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

January 30, 2017

First Posted

November 13, 2017

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 25, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share