NCT03408834

Brief Summary

This study was to find out whether laparoscopic colorectal surgery is detrimental to the kidneys via PVI monitoring. To detect the kidney injury, so-called kidney troponin NGAL ,which gives earlier information than creatin in renal ischemic injury, was used.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

January 17, 2018

Last Update Submit

January 25, 2018

Conditions

Laparoscopic Colorectal SurgeryAcute Kidney Injury

Keywords

NGALPVI

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of acute kidney injury

    following up diagnosis of acute kidney injury

    postoperative 6 th hour

Study Arms (2)

pulse variability index

ACTIVE COMPARATOR

fluid management performed by pulse variability index

Other: pulse variability index

conventional fluid management

PLACEBO COMPARATOR

fluid management performed by conventional fluid management

Other: pulse variability index

Interventions

pulse variability indexOTHER

fluid management with pulse variability index or conventional

Also known as: conventional
conventional fluid managementpulse variability index

Eligibility Criteria

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

You may qualify if:

  • laparoscopic surgery
  • obese patient

You may not qualify if:

  • patient refusal
  • major comorbidity
  • renal failure
  • diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • CIGDEM YILDIRIMGUCLU

    Ankara University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 24, 2018

Study Start

January 2, 2016

Primary Completion

September 2, 2017

Study Completion

October 2, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share