Acute Kidney Injury (Nontraumatic)NCT05612802
A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)
A study testing IGF-1 in people with Acute Kidney Injury (Nontraumatic) and Pneumoperitoneum, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
In our study, to show the effect of pneumoperitoneum on acute kidney injury in patients scheduled for laparoscopic surgery, NGAL and IGF-1 values will be measured before, after and 24 hours after pneumoperitoneum, and these values will be compared. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury (Nontraumatic), Pneumoperitoneum
- What is being tested?
- IGF-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2023to 30 May 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years of both sexes
- ASA I-III Patients
Who cannot join
- Obesity,
- Chronic Kidney Disease,
- Chronic Renal Failure,
- Acute Renal Failure,
- Peripheral and ischemic vascular disease,
- Chronic Heart Failure,
Show all 18Show fewer
- History of anaphylaxis,
- A-V block,
- Creatinine level >1.4,
- Neuromuscular disease,
- Malignant hypertension,
- Pyelonephritis,
- Urinary tract infectio,
- Severe inflammation/possible sepsis,
- Active malignancy,
- Patients with surgery reversion to laparotomy,
- Hemodynamic instability, need for vasopressors,
- Severe bleeding requiring blood transfusion,
Trial locations and contacts
1 site in 1 country.
About this study
In our study, to show the effect of pneumoperitoneum on acute kidney injury in patients scheduled for laparoscopic surgery, NGAL and IGF-1 values will be measured before, after and 24 hours after pneumoperitoneum, and these values will be compared. In our study, we aimed to investigate the effect of pneumoperitoneum applied on acute kidney injury in patients who underwent laparoscopic surgery. Creatinine and NGAL have been used successfully in the follow-up of acute kidney injury. Our study investigates whether IGF-1 will be an effective indicator in acute kidney injury by comparing IGF-1 and NGAL values before pneumoperitoneum, after pneumoperitoneum and at the postoperative 24th hour.
- Being tested
- IGF-1
- Medical subject headings
- Acute Kidney Injury, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGF-1Diagnostic test
We need to diagnose acute kidney injury in the early postoperative period. The markers examined so far do not provide enough information to diagnose acute kidney injury early. For this reason, many different biomarkers are used in the early diagnosis of acute kidney injury in many parts of the world. Thanks to our research, we can recognise the development of acute kidney injury at an early stage and determine whether a previously unused biomarker (IGF-1) is effective in the early diagnosis of acute kidney injury.
| Study group | Role | What they receive |
|---|---|---|
| IGF | Other | Creatinine and NGAL have been used successfully in the follow-up of acute kidney injury. In our study, in order to show the effect of pneumoperitoneum on acute kidney injury in patients scheduled for laparoscopic surgery, NGAL and IGF-1 values will be measured before, after and 24 hours after pneumoperitoneum, and these values will be compared. Receives: Diagnostic Test: IGF-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of acute kidney injury in the early postoperative period with IGF-1 (insulin like growth factor-1)
The researchers investigate whether IGF-1 will be an effective indicator in acute kidney injury by comparing IGF-1 and NGAL (Neutrophil gelatinase-associated lipocalin) values before pneumoperitoneum, after pneumoperitoneum and at the postoperative 24th hour.
Measured: before pneumoperitoneum, after pneumoperitoneum, and at the postoperative 24th hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start8 Feb 2023
- Primary completion30 Mar 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Injury (Nontraumatic)Studies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağla Yazar, MD, Baskent University
- Investigators
- NEDİM ÇEKMEN, PHD, Study director, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612802
- Sponsor's protocol ID
- KA22/178
- Status last verified
- Jan 2024
- First submitted
- 6 Sep 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gumbert SD, Kork F, Jackson ML, Vanga N, Ghebremichael SJ, Wang CY, Eltzschig HK. Perioperative Acute Kidney Injury. Anesthesiology. 2020 Jan;132(1):180-204. doi: 10.1097/ALN.0000000000002968.
PubMed 31687986Marton Filho MA, Alves RL, Nascimento PD Junior, Tarquinio GDS, Mega PF, Pinheiro Modolo NS. Effects of pneumoperitoneum on kidney injury biomarkers: A randomized clinical trial. PLoS One. 2021 Feb 19;16(2):e0247088. doi: 10.1371/journal.pone.0247088. eCollection 2021.
PubMed 33606739Sun B, Fu A, Wang R, Zhang Y. Influence of carbon dioxide pneumoperitoneum on the growth hormone-insulin-like growth factor I axis in mid- and late-pregnancy rats. J Obstet Gynaecol Res. 2015 Sep;41(9):1394-8. doi: 10.1111/jog.12734. Epub 2015 Jun 22.
PubMed 26098754Srisawat N, Kongwibulwut M, Laoveeravat P, Lumplertgul N, Chatkaew P, Saeyub P, Latthaprecha K, Peerapornratana S, Tiranathanagul K, Eiam-Ong S, Tungsanga K. The role of intraoperative parameters on predicting laparoscopic abdominal surgery associated acute kidney injury. BMC Nephrol. 2018 Oct 22;19(1):289. doi: 10.1186/s12882-018-1081-4.
PubMed 30348111
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)
- ClinicalTrials.gov ID
- NCT05612802
- Acronym / sponsor ID
- KA22/178
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 10 Nov 2022 (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.
In our study, to show the effect of pneumoperitoneum on acute kidney injury in patients scheduled for laparoscopic surgery, NGAL and IGF-1 values will be measured before, after and 24 hours after pneumoperitoneum, and these values will be compared. In our study, we aimed to investigate the effect of pneumoperitoneum applied on acute kidney injury in patients who underwent laparoscopic surgery. Creatinine and NGAL have been used successfully in the follow-up of acute kidney injury. Our study investigates whether IGF-1 will be an effective indicator in acute kidney injury by comparing IGF-1 and NGAL values before pneumoperitoneum, after pneumoperitoneum and at the postoperative 24th hour.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IGF | Other | Diagnostic Test: IGF-1Creatinine and NGAL have been used successfully in the follow-up of acute kidney injury. In our study, in order to show the effect of pneumoperitoneum on acute kidney injury in patients scheduled for laparoscopic surgery, NGAL and IGF-1 values will be measured before, after and 24 hours after pneumoperitoneum, and these values will be compared. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-70 years of both sexes
- ASA I-III Patients
Key exclusion criteria (18 listed)
- Obesity,
- Chronic Kidney Disease,
- Chronic Renal Failure,
- Acute Renal Failure,
- Peripheral and ischemic vascular disease,
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 |
|---|---|---|
| IGF-1We need to diagnose acute kidney injury in the early postoperative period. The markers examined so far do not provide enough information to diagnose acute kidney injury early. For this reason, many different biomarkers are used in the early diagnosis of acute kidney injury in many parts of the world. Thanks to our research, we can recognise the development of acute kidney injury at an early stage and determine whether a previously unused biomarker (IGF-1) is effective in the early diagnosis of acute kidney injury. | Diagnostic test | IGF |
Primary outcome
Diagnosis of acute kidney injury in the early postoperative period with IGF-1 (insulin like growth factor-1)
Time frame: before pneumoperitoneum, after pneumoperitoneum, and at the postoperative 24th hour.
The researchers investigate whether IGF-1 will be an effective indicator in acute kidney injury by comparing IGF-1 and NGAL (Neutrophil gelatinase-associated lipocalin) values before pneumoperitoneum, after pneumoperitoneum and at the postoperative 24th hour.
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 5 Jan 2024.
- Background: PubMed 31687986Gumbert SD, Kork F, Jackson ML, Vanga N, Ghebremichael SJ, Wang CY, Eltzschig HK. Perioperative Acute Kidney Injury. Anesthesiology. 2020 Jan;132(1):180-204. doi: 10.1097/ALN.0000000000002968.
- Background: PubMed 33606739Marton Filho MA, Alves RL, Nascimento PD Junior, Tarquinio GDS, Mega PF, Pinheiro Modolo NS. Effects of pneumoperitoneum on kidney injury biomarkers: A randomized clinical trial. PLoS One. 2021 Feb 19;16(2):e0247088. doi: 10.1371/journal.pone.0247088. eCollection 2021.
- Background: PubMed 26098754Sun B, Fu A, Wang R, Zhang Y. Influence of carbon dioxide pneumoperitoneum on the growth hormone-insulin-like growth factor I axis in mid- and late-pregnancy rats. J Obstet Gynaecol Res. 2015 Sep;41(9):1394-8. doi: 10.1111/jog.12734. Epub 2015 Jun 22.
- Background: PubMed 30348111Srisawat N, Kongwibulwut M, Laoveeravat P, Lumplertgul N, Chatkaew P, Saeyub P, Latthaprecha K, Peerapornratana S, Tiranathanagul K, Eiam-Ong S, Tungsanga K. The role of intraoperative parameters on predicting laparoscopic abdominal surgery associated acute kidney injury. BMC Nephrol. 2018 Oct 22;19(1):289. doi: 10.1186/s12882-018-1081-4.
- Individual participant dataSharing planned: No
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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.
NEDİM ÇEKMEN, PHD study director
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IGF-1 in people with Acute Kidney Injury (Nontraumatic) and Pneumoperitoneum, run by Baskent University at 1 site in Turkey (Türkiye).
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 18 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 in the early postoperative period with IGF-1 (insulin like growth factor-1) (time frame: before pneumoperitoneum, after pneumoperitoneum, and at the postoperative 24th hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612802, which also lists 4 linked publications.
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 5 Jan 2024.