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

NCT03219398 | Completed

• 1 other identifier: IndonesiaUAnes020
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Living donor laparoscopic nephrectomy; Pneumoperitoneum; Renal resistive index; Syndecan-1; soluble VEGF-R2; Occludin; KIM-1; Interleukin-6

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Changes in Renal Resistive Index from baseline

  24 hours

• Renal biopsy tissue Syndecan-1

  24 hours

• Intraoperative fentanyl dosage

  24 hours

• Changes in Occludin level from baseline

  24 hours

Study Arms (2)

8-10 mmHg

ACTIVE COMPARATOR

Patients receive lower pneumoperitoneum pressure

Procedure: Pneumoperitoneum pressure

12-14 mmHg

ACTIVE COMPARATOR

Patients receive higher pneumoperitoneum pressure

Procedure: Pneumoperitoneum pressure

Interventions

Pneumoperitoneum pressure PROCEDURE

Subjects were set to 8- 10 mmHg pressure during laparoscopic surgery; Subjects were set to 12-14 mmHg pressure during laparoscopic surgery

12-14 mmHg; 8-10 mmHg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

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  BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Dita Aditianingsih, MD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist Consultant, Principal Investigator

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 17, 2017
• Study Start: August 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 14, 2019

Record last verified: 2019-03

Locations

ID (1)