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The Effect of Lower Intraabdominal Pressure on Syndecan-1, sVEGF-R2, Occludin, KIM-1, and IL-6 on Living Donor Laparoscopic Nephrectomy

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ClinicalTrials.gov Identifier: NCT03219398
Recruitment Status : Completed
First Posted : July 17, 2017
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Dita Aditianingsih, Indonesia University

Brief Summary:
This study aimed to evaluate the increase of intraabdominal pressure 12- 14 mmHg caused by pneumoperitoneum resulted from carbon dioxide (CO2) insufflation induce glycocalyx endothelial injury that cause kidney tubular injury on live donor patient that undergo laparoscopic nephrectomy surgery, and decreasing the intraabdominal pressure to 8-10 mmHg during surgery is expected to reduce the injury.

Condition or disease Intervention/treatment Phase
Healthy Procedure: Pneumoperitoneum pressure Not Applicable

Detailed Description:
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups. Intravenous (IV) cannula (18-20G) with Ringer Lactate fluid, non-invasive blood pressure monitor, electrocardiogram (ECG), ICON® monitor, hemodynamic monitor and pulse-oxymetry were set on the subjects in the operation room. Premedication with 2 mg IV midazolam and 1 mcg/kg IV fentanyl as premedication. General anesthesia induction was done by fentanyl 4 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0,5 mg/kg. Maintenance was done by sevoflurane 1 minimum alveolar concentration (MAC), fentanyl and rocuronium with bupivacaine bolus 6ml every 90 minutes. Surgery starts with patient in lumbotomy position laterally, CO2 gas insufflated during the installment of laparoscopy probe until it reaches 10- 12 mmHg pressure. Laparoscopy targeted the pneumoperitoneum pressure until 8- 10 mmHg or 12- 14 mmHg depends on subject randomization. Surgery duration, blood pressure, heart rate, respiratory rate, oxygen saturation (SpO2) were recorded. During surgery, blood sample for interleukin (IL)-6, Syndecan-1, sVGEF-R2, Occludin and KIM-1 urine were taken before the anesthesia induction as the baseline; 2 hours of gas insufflation intraoperatively; and 2 hours after gas desufflation. The measurement of renal artery and kidney lobe artery that undergo nephrectomy, will be measured by convex probe 3.5-5 megahertz (MHz) ultrasonography (USG) Logic 7-GE or Sonosite. The measurement of RI was done on the left kidney at the time: before the anesthesia induction as the baseline; 2 hours of gas insufflation intraoperatively; and 2 hours after gas desufflation on the remaining right kidney. All patients received bilateral Quadratus Lumborum (QL) block using bupivacaine 0.25% before extubation. Patient were extubated until fully conscious and can follow command verbally. Patient will be transported in recovery room post operation. Data was analyzed using SPSS (Statistical Package for Social Scientist), for parametric unpaired data is using unpaired T-test or One way ANOVA test, ffor unpaired non parametric data using Mann Whitney or Kruskal-Wallis. Non Parametric continuous data using Wilcoxon's signed rank test or Friedman Test. Categorical data using Chi-square. For numerical data more than 1 measurement will be analysed using Comparative General Linear Model. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison Effect Between Lower Pressure and Standard Pressure Pneumoperitoneum on Sign of Acute Systemic Inflammation, Endothelial Injury, and Acute Kidney Injury: A Randomized Clinical Trial in Living Donor Laparoscopic Nephrectomy
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : December 1, 2018

Arm Intervention/treatment
Active Comparator: 8-10 mmHg
Patients receive lower pneumoperitoneum pressure
Procedure: Pneumoperitoneum pressure
Subjects were set to 8- 10 mmHg pressure during laparoscopic surgery; Subjects were set to 12-14 mmHg pressure during laparoscopic surgery

Active Comparator: 12-14 mmHg
Patients receive higher pneumoperitoneum pressure
Procedure: Pneumoperitoneum pressure
Subjects were set to 8- 10 mmHg pressure during laparoscopic surgery; Subjects were set to 12-14 mmHg pressure during laparoscopic surgery




Primary Outcome Measures :
  1. Changes in Syndecan-1 level from baseline [ Time Frame: 24 hours ]
    Measurement of plasma Syndecan-1 level after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation

  2. Changes in sVGEFR-2 level from baseline [ Time Frame: 24 hours ]
    Measurement of plasma soluble VGEF-R2 level after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation

  3. Changes in KIM-1 level from baseline [ Time Frame: 24 hours ]
    Measurement of Urinary KIM-1 level after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation

  4. Changes in Interleukin-6 from baseline [ Time Frame: 24 hours ]
    Measurement of plasma Interleukin-6 after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation


Secondary Outcome Measures :
  1. Changes in Renal Resistive Index from baseline [ Time Frame: 24 hours ]
    Measurement of Renal artery resistive index using ultrasound after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation

  2. Renal biopsy tissue Syndecan-1 [ Time Frame: 24 hours ]
    Histopathology and immunostaining Syndecan-1 of renal biopsy after donor kidney has been removed from patient and stored in ice

  3. Intraoperative fentanyl dosage [ Time Frame: 24 hours ]
    Comparison of fentanyl needs during operation

  4. Changes in Occludin level from baseline [ Time Frame: 24 hours ]
    Measurement of plasma Occludin level after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects aged 18-60 years old undergoing laparoscopic surgery, with American Society of Anesthesiologist (ASA) 1, body mass index 18-25. Patients who agreed to participate in this study and sign informed consent.

Exclusion Criteria:

  • Subjects in the outside criteria of American Society of Anesthesia 1, body mass index >25.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219398


Locations
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Indonesia
Cipto Mangunkusumo Central National Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Dita Aditianingsih, MD Indonesia University

Publications:
De Souza D, Costa WS, Cardoso LEM, Benchimol M, Pereira-Sampaio MA, Sampaio FJB. Prolonged pneumoperitoneum did not harm the kidney in a rat model. J Urol 2012;187(4):412-3.
United States Renal Data System. USRDS 2013 annual data report: atlas of chronic kidney disease and end-stage re- nal disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2013.
Department of Health and Human Services, Health Resources and Services Administration. Organ Procurement and Transplantation Network. Available from URL: http:// optn.transplant.hrsa.gov/converge/latest- Data/rptData.asp.
Harjito FV. One-Year Survival of Kidney Transplant Recipients in Cipto Mangunkusumo Hospital. Perpustakaan Fakultas Kedokteran Universitas Indonesia 2015. Available from URL: http://perpustakaan.fk.ui.ac.id/opac/index.resipien+transplantasi+ginjal.
Barth RN. Donor Nephrectomy. Kidney Transplantation Principle 2013;8:118-29.
Hayat MA. Principles and Techniques of Electron Microscopy, London, Macmillan, 1989, p288
Barker AL, Konopatskaya O, Neal CR, Macpherson JV, Whatmore JL, Winlove CP, Unwin PR, Shore AC. Observation and characterisation of the glycocalyx of viable human endothelial cells using confocal laser scanning microscopy. Phys Chem Chem Phys 2004;6:1006-1011.
Herdan RA, Ibrahim AS, El-Gammal SAM, Bakr MAM, Latif MA, Ibraheem HA. Gastric Mucosal End-Tidal Carbon Dioxide Partial Pressure Difference as a Continuous Indicator of Splanchnic Perfusion During Prolonged Anesthesia. Med J Cairo Univ 2013; 18:(1): 359-65.
Mostafa G, Greene FL. Fluid Management and Renal Function During a Laparoscopic Case Done Under CO2 Pneumoperitoneum. In: Scott-Conner CEH, editors. Fundamental of laparoscopy, thoracoscopy and GI Endoscopy. 2nd ed. New York: Springer; 2014.

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Responsible Party: Dita Aditianingsih, Anesthesiologist Consultant, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03219398     History of Changes
Other Study ID Numbers: IndonesiaUAnes020
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dita Aditianingsih, Indonesia University:
Living donor laparoscopic nephrectomy
Pneumoperitoneum
Renal resistive index
Syndecan-1
soluble VEGF-R2
Occludin
KIM-1
Interleukin-6

Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases