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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03408834
Other study ID # 15-823-16
Secondary ID
Status Completed
Phase N/A
First received January 17, 2018
Last updated January 25, 2018
Start date January 2, 2016
Est. completion date October 2, 2017

Study information

Verified date January 2018
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Our object in 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 creatine in renal ischemic injury, was used.

Patients undergoing elective laparoscopic colorectal surgery, 18 to 75 years old, planned surgery duration longer than 2 hours, were included in this study. Patients were divided into 2 groups with respect to their fluid resuscitation, Group 1: goal directed fluid therapy via PVI monitoring Group 2: conventional fluid resuscitation. Blood samples were drawn from both groups for NGAL measurement before CO2 insufflation (T0), and at 6th(T1) and 12th(T2) hours after CO2 insufflation. At the end of the surgery, sugammadex was given to all patients for reversal of muscular blockade.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date October 2, 2017
Est. primary completion date September 2, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- laparoscopic surgery

- obese patient

Exclusion Criteria:

- patient refusal

- major comorbidity

- renal failure

- diabetes mellitus

Study Design


Intervention

Other:
pulse variability index
fluid management with pulse variability index or conventional

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara University

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of acute kidney injury following up diagnosis of acute kidney injury postoperative 6 th hour
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