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

Primary Purpose

Acute Kidney Injury (Nontraumatic), Pneumoperitoneum

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IGF-1
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Kidney Injury (Nontraumatic)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    IGF

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 6, 2022
    Last Updated
    February 6, 2023
    Sponsor
    Baskent University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05612802
    Brief Title
    A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)
    Official Title
    A New Marker for Early Diagnosis of Pneumoperitoneum-Related Acute Kidney Injury: Insulin-Like Growth Factor-1 (IGF-1)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 8, 2023 (Anticipated)
    Primary Completion Date
    March 30, 2023 (Anticipated)
    Study Completion Date
    May 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baskent University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Kidney Injury (Nontraumatic), Pneumoperitoneum

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IGF
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    IGF-1
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Diagnosis of acute kidney injury in the early postoperative period with IGF-1 (insulin like growth factor-1)
    Description
    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.
    Time Frame
    before pneumoperitoneum, after pneumoperitoneum, and at the postoperative 24th hour.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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,
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Çağla Yazar, MD
    Phone
    05454160779
    Email
    cglyzr@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    DENADA HAKA, MD
    Email
    denadahaka97@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    NEDİM ÇEKMEN, PHD
    Organizational Affiliation
    Baskent University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31687986
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33606739
    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.
    Results Reference
    background
    PubMed Identifier
    26098754
    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.
    Results Reference
    background
    PubMed Identifier
    30348111
    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.
    Results Reference
    background

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

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