A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)
1 other identifier
interventional
25
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2022
CompletedFirst Posted
Study publicly available on registry
November 10, 2022
CompletedStudy Start
First participant enrolled
February 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedJanuary 5, 2024
January 1, 2024
2 months
September 6, 2022
January 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
before pneumoperitoneum, after pneumoperitoneum, and at the postoperative 24th hour.
Study Arms (1)
IGF
OTHERCreatinine 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients aged 18-70 years of both sexes
- ASA I-III Patients
You may not qualify if:
- Obesity,
- Chronic Kidney Disease,
- Chronic Renal Failure,
- Acute Renal Failure,
- Peripheral and ischemic vascular disease,
- Chronic Heart Failure,
- History of anaphylaxis,
- A-V block,
- Creatinine level \>1.4,
- Neuromuscular disease,
- Malignant hypertension,
- Pyelonephritis,
- Urinary tract infectio,
- Severe inflammation/possible sepsis,
- Active malignancy,
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Çağla Yazar, MD
Ankara, 06560, Turkey (Türkiye)
Related Publications (4)
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.
PMID: 31687986BACKGROUNDMarton 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.
PMID: 33606739BACKGROUNDSun 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.
PMID: 26098754BACKGROUNDSrisawat 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.
PMID: 30348111BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
NEDİM ÇEKMEN, PHD
Baskent University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
September 6, 2022
First Posted
November 10, 2022
Study Start
February 8, 2023
Primary Completion
March 30, 2023
Study Completion
May 30, 2023
Last Updated
January 5, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share