A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)

Pneumoperitoneum Clinical Trial

Official title:

A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05612802
• Other study ID #: KA22/178
• Status: Completed
• Phase: N/A
• Start date: February 8, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: January 2024
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-70 years of both sexes
• ASA I-III Patients

Exclusion Criteria:

• 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,
• Patients with surgery reversion to laparotomy,
• Hemodynamic instability, need for vasopressors,
• Severe bleeding requiring blood transfusion,

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury (Nontraumatic)
• Pneumoperitoneum
• Wounds and Injuries

Intervention

Diagnostic Test:
• IGF-1
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.

Locations

Country	Name	City	State
Turkey	Çagla Yazar, MD	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Marton 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. — View Citation

Srisawat 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. — View Citation

Sun 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.