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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219398
• Other study ID #: IndonesiaUAnes020
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Pneumoperitoneum

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

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* Note: There are 122 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Syndecan-1 level from baseline	Measurement of plasma Syndecan-1 level after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation	24 hours
Primary	Changes in sVGEFR-2 level from baseline	Measurement of plasma soluble VGEF-R2 level after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation	24 hours
Primary	Changes in KIM-1 level from baseline	Measurement of Urinary KIM-1 level after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation	24 hours
Primary	Changes in Interleukin-6 from baseline	Measurement of plasma Interleukin-6 after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation	24 hours
Secondary	Changes in Renal Resistive Index from baseline	Measurement of Renal artery resistive index using ultrasound after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation	24 hours
Secondary	Renal biopsy tissue Syndecan-1	Histopathology and immunostaining Syndecan-1 of renal biopsy after donor kidney has been removed from patient and stored in ice	24 hours
Secondary	Intraoperative fentanyl dosage	Comparison of fentanyl needs during operation	24 hours
Secondary	Changes in Occludin level from baseline	Measurement of plasma Occludin level after patient is sedated at baseline, 2 hours insufflation, and 2 hours after desufflation	24 hours