Laparoscopic Colorectal SurgeryNCT03408834
The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese Patients
A study testing pulse variability index in people with Laparoscopic Colorectal Surgery and Acute Kidney Injury, run by Ankara University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Colorectal Surgery, Acute Kidney Injury
- What is being tested?
- pulse variability index
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2016to 2 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- laparoscopic surgery
- obese patient
Who cannot join
- patient refusal
- major comorbidity
- renal failure
- diabetes mellitus
About this study
Official title: The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese
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.
Read the detailed 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.
- Being tested
- pulse variability index
- Keywords
- NGAL, PVI
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulse variability indexOther
Also called conventional
fluid management with pulse variability index or conventional
| Study group | Role | What they receive |
|---|---|---|
| pulse variability index | Active comparator | fluid management performed by pulse variability index Receives: Other: pulse variability index |
| conventional fluid management | Placebo comparator | fluid management performed by conventional fluid management Receives: Other: pulse variability index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of acute kidney injury
following up diagnosis of acute kidney injury
Measured: postoperative 6 th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start2 Jan 2016
- Primary completion2 Sep 2017
- Study completion2 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
- Investigators
- CIGDEM YILDIRIMGUCLU, Study chair, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408834
- Sponsor's protocol ID
- 15-823-16
- Status last verified
- Jan 2018
- First submitted
- 17 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese
- ClinicalTrials.gov ID
- NCT03408834
- Acronym / sponsor ID
- 15-823-16
- Keywords
- NGAL, PVI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 2 Sep 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulse variability index | Active comparator | Other: pulse variability indexfluid management performed by pulse variability index |
| conventional fluid management | Placebo comparator | Other: pulse variability indexfluid management performed by conventional fluid management |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- laparoscopic surgery
- obese patient
Key exclusion criteria (4 listed)
- patient refusal
- major comorbidity
- renal failure
- diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulse variability indexAlso: conventionalfluid management with pulse variability index or conventional | Other | conventional fluid management, pulse variability index |
Primary outcome
Diagnosis of acute kidney injury
Time frame: postoperative 6 th hour
following up diagnosis of acute kidney injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Laparoscopic Colorectal Surgery
RecruitingPhase 3
Intravenous Lidocaine Plus Port-Site Ropivacaine for Recovery After Laparoscopic Surgery
Intravenous Lidocaine, Laparoscopic Surgery
Recruiting
Quality of Recovery After Colorectal Surgery (Robots vs Laparoscopic)
Recovery Outcomes
Recruiting
Effect of Oral Laxative Use Before Colorectal Surgery on Intraoperative Surgical Difficulty
Colorectal Diseases, Mechanical Bowel Preparation
Active, not recruitingPhase 1/2
Opioid-Free Anesthesia in Colorectal Surgery, 2025 (OFA-CRC-2025)
Pain Management, Colorectal Surgery
RecruitingObservational study
Internal Jugular Vein Collapsibility Index as a Predictor of Hypotension
Intraoperative Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CIGDEM YILDIRIMGUCLU study chair
Ankara University
Questions about this trial
What is this clinical trial studying?
A study testing pulse variability index in people with Laparoscopic Colorectal Surgery and Acute Kidney Injury, run by Ankara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of acute kidney injury (time frame: postoperative 6 th hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.