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

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 Overview

• Status: Completed
• Conditions: Pneumoperitoneum; Acute Kidney Injury (Nontraumatic)
• Intervention / Treatment: Diagnostic test: IGF-1

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Çağla Yazar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: IGF; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Baskent University
• Investigators: Study Director: NEDİM ÇEKMEN, PHD, Baskent University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Kidney Diseases; Urologic Diseases; Peritoneal Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pneumoperitoneum; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: KA22/178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No