NCT04855318

Brief Summary

The frequency of obese postoperative rhabdomyolized acute tubular necrosis (ATN) and renal failure is also increasing. It is simply important to manage fluid. The fluid requirement should be higher than planned. In order to learn the postoperative ATN and the development of renal failure, 4-5 lt crystalloid fluid should be given in 2-3 times or 1.5 ml / kg / h should be provided in the upper outlet. According to TVA, there are no good guidelines for intraoperative fluid management in bariatric surgery. Different intraoperative fluid management communications are used. The key to improving outcomes from post-operative treatment is "patient directed fluid management" or "targeted fluid management". The use of Perioperative Goal-Directed Fluid Therapy Technologies helps the anesthesiologist closely monitor the patient and strike the delicate balance between benefit and risk. Plethysmographic variability index monitoring (PVI-Pleth Variability Index) is a non-invasive, automatic and continuous monitor that displays patient fluid response, it is one of the easily applicable and easily interpreted monitoring methods. With PVI monitoring, intraoperative hypotension and fluid need can be predicted in advance. Plethysmographic Variability Index (PVI) is the determination of the importance of monitoring of intraoperative volume replacement and its effect on postoperative operations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
Last Updated

March 31, 2022

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

April 4, 2021

Last Update Submit

March 18, 2022

Conditions

Keywords

obesityfluid therapypleth variability index

Outcome Measures

Primary Outcomes (1)

  • Fluid therapy in bariatric patients

    Fluid therapy is providewith pleth variability index monitorisation

    during surgery

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

sample size 60

You may qualify if:

  • obese patients who scheduled for elective bariatric surgery

You may not qualify if:

  • severe cardiac arrhythmia
  • peripheral artery disease
  • an ejection fraction \<30%
  • any pulmonary pathology preventing a respiratory volume \>6 ml/kg/min on mechanical ventilation
  • hepatic or renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • MELIHA ORHON ERGUN

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 4, 2021

First Posted

April 22, 2021

Study Start

January 10, 2021

Primary Completion

March 10, 2021

Study Completion

March 20, 2021

Last Updated

March 31, 2022

Record last verified: 2021-06

Locations