HealthyNCT03219398
The Effect of Lower Intraabdominal Pressure on Syndecan-1, sVEGF-R2, Occludin, KIM-1, and IL-6 on Living Donor Laparoscopic Nephrectomy
A study testing Pneumoperitoneum pressure in people with Healthy, run by Universitas Indonesia at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pneumoperitoneum pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Subjects in the outside criteria of American Society of Anesthesia 1, body mass index >25.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta, DKI Jakarta, 10430
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Pneumoperitoneum pressure
- Keywords
- Living donor laparoscopic nephrectomy, Pneumoperitoneum, Renal resistive index, Syndecan-1, soluble VEGF-R2, Occludin, KIM-1, Interleukin-6
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumoperitoneum pressureProcedure or surgery
Subjects were set to 8- 10 mmHg pressure during laparoscopic surgery; Subjects were set to 12-14 mmHg pressure during laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| 8-10 mmHg | Active comparator | Patients receive lower pneumoperitoneum pressure Receives: Procedure: Pneumoperitoneum pressure |
| 12-14 mmHg | Active comparator | Patients receive higher pneumoperitoneum pressure Receives: Procedure: Pneumoperitoneum pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours
Secondary outcomes (4)
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
Measured: 24 hours
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
Measured: 24 hours
Intraoperative fentanyl dosage
Comparison of fentanyl needs during operation
Measured: 24 hours
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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start1 Aug 2017
- Primary completion1 Mar 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (122)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dita Aditianingsih, Universitas Indonesia
- Investigators
- Dita Aditianingsih, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219398
- Sponsor's protocol ID
- IndonesiaUAnes020
- Status last verified
- Mar 2019
- First submitted
- 12 Jul 2017
- Last updated
- 14 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fehrman-Ekholm I, Lennerling A, Kvarnstrom N, Rizell M, Olausson M. [Living donor kidney transplantation--a successful story. Very cost-effective--and the donors live long with good health]. Lakartidningen. 2011 Nov 30-Dec 6;108(48):2492-5. No abstract available. Swedish.
PubMed 22462270Choi JD, Park JW, Choi JY, Kim HS, Jeong BC, Jeon SS, Lee HM, Choi HY, Seo SI. Renal damage caused by warm ischaemia during laparoscopic and robot-assisted partial nephrectomy: an assessment using Tc 99m-DTPA glomerular filtration rate. Eur Urol. 2010 Dec;58(6):900-5. doi: 10.1016/j.eururo.2010.08.044. Epub 2010 Sep 15.
PubMed 21414862Vasdev N, Poon AS, Gowrie-Mohan S, Lane T, Boustead G, Hanbury D, Adshead JM. The physiologic and anesthetic considerations in elderly patients undergoing robotic renal surgery. Rev Urol. 2014;16(1):1-9.
PubMed 24791150Dalfino L, Tullo L, Donadio I, Malcangi V, Brienza N. Intra-abdominal hypertension and acute renal failure in critically ill patients. Intensive Care Med. 2008 Apr;34(4):707-13. doi: 10.1007/s00134-007-0969-4. Epub 2007 Dec 19.
PubMed 18157662Mohmand H, Goldfarb S. Renal dysfunction associated with intra-abdominal hypertension and the abdominal compartment syndrome. J Am Soc Nephrol. 2011 Apr;22(4):615-21. doi: 10.1681/ASN.2010121222. Epub 2011 Feb 10.
PubMed 21310818Nguyen NT, Perez RV, Fleming N, Rivers R, Wolfe BM. Effect of prolonged pneumoperitoneum on intraoperative urine output during laparoscopic gastric bypass. J Am Coll Surg. 2002 Oct;195(4):476-83. doi: 10.1016/s1072-7515(02)01321-2.
PubMed 12375752Garg AX, Muirhead N, Knoll G, Yang RC, Prasad GV, Thiessen-Philbrook H, Rosas-Arellano MP, Housawi A, Boudville N; Donor Nephrectomy Outcomes Research (DONOR) Network. Proteinuria and reduced kidney function in living kidney donors: A systematic review, meta-analysis, and meta-regression. Kidney Int. 2006 Nov;70(10):1801-10. doi: 10.1038/sj.ki.5001819. Epub 2006 Sep 27.
PubMed 17003822Gomez-Anson B, Carrero-Lopez V, Diaz-Gonzalez R. Image-directed color Doppler ultrasound evaluation of the single kidney after unilateral nephrectomy in adults. J Clin Ultrasound. 1997 Jan;25(1):29-35. doi: 10.1002/(sici)1097-0096(199701)25:13.0.co;2-m.
PubMed 9010805Nekouei S, Ahmadnia H, Abedi M, Alamolhodaee MH, Abedi MS. Resistive index of the remaining kidney in allograft kidney donors. Exp Clin Transplant. 2012 Oct;10(5):454-7. doi: 10.6002/ect.2012.0054.
PubMed 23031084Lindberg F, Bergqvist D, Bjorck M, Rasmussen I. Renal hemodynamics during carbon dioxide pneumoperitoneum: an experimental study in pigs. Surg Endosc. 2003 Mar;17(3):480-4. doi: 10.1007/s00464-002-9044-y. Epub 2002 Nov 6.
PubMed 12415336Wiesenthal JD, Fazio LM, Perks AE, Blew BD, Mazer D, Hare G, Honey RJ, Pace KT. Effect of pneumoperitoneum on renal tissue oxygenation and blood flow in a rat model. Urology. 2011 Jun;77(6):1508.e9-15. doi: 10.1016/j.urology.2011.02.022. Epub 2011 Apr 19.
PubMed 21507469Zacherl J, Thein E, Stangl M, Feussner H, Bock S, Mittlbock M, Erhardt W, Siewert JR. The influence of periarterial papaverine application on intraoperative renal function and blood flow during laparoscopic donor nephrectomy in a pig model. Surg Endosc. 2003 Aug;17(8):1231-6. doi: 10.1007/s00464-002-8835-5. Epub 2003 Jun 13.
PubMed 12799887Gudmundsson FF, Viste A, Myking OL, Bostad L, Grong K, Svanes K. Role of angiotensin II under prolonged increased intraabdominal pressure (IAP) in pigs. Surg Endosc. 2003 Jul;17(7):1092-7. doi: 10.1007/s00464-002-9123-0. Epub 2003 Mar 14.
PubMed 12632126Borba MR, Lopes RI, Carmona M, Neto BM, Nahas SC, Pereira PR. Effects of enalaprilat on the renin-angiotensin-aldosterone system and on renal function during CO2 pneumoperitoneum. J Endourol. 2005 Oct;19(8):1026-31. doi: 10.1089/end.2005.19.1026.
PubMed 16253075Demyttenaere S, Feldman LS, Fried GM. Effect of pneumoperitoneum on renal perfusion and function: a systematic review. Surg Endosc. 2007 Feb;21(2):152-60. doi: 10.1007/s00464-006-0250-x. Epub 2006 Dec 9.
PubMed 17160650
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03219398
- Acronym / sponsor ID
- IndonesiaUAnes020
- Conditions
- Healthy
- Keywords
- Living donor laparoscopic nephrectomy, Pneumoperitoneum, Renal resistive index, Syndecan-1, soluble VEGF-R2, Occludin, KIM-1, Interleukin-6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8-10 mmHg | Active comparator | Procedure: Pneumoperitoneum pressurePatients receive lower pneumoperitoneum pressure |
| 12-14 mmHg | Active comparator | Procedure: Pneumoperitoneum pressurePatients receive higher pneumoperitoneum pressure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects in the outside criteria of American Society of Anesthesia 1, body mass index >25.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumoperitoneum pressureSubjects were set to 8- 10 mmHg pressure during laparoscopic surgery; Subjects were set to 12-14 mmHg pressure during laparoscopic surgery | Procedure or surgery | 12-14 mmHg, 8-10 mmHg |
Primary outcome
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
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
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
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
4 secondary outcomes
Changes in Renal Resistive Index from baseline
Time frame: 24 hours
Renal biopsy tissue Syndecan-1
Time frame: 24 hours
Intraoperative fentanyl dosage
Time frame: 24 hours
Changes in Occludin level from baseline
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Background: PubMed 22462270Fehrman-Ekholm I, Lennerling A, Kvarnstrom N, Rizell M, Olausson M. [Living donor kidney transplantation--a successful story. Very cost-effective--and the donors live long with good health]. Lakartidningen. 2011 Nov 30-Dec 6;108(48):2492-5. No abstract available. Swedish.
- Background: PubMed 21414862Choi JD, Park JW, Choi JY, Kim HS, Jeong BC, Jeon SS, Lee HM, Choi HY, Seo SI. Renal damage caused by warm ischaemia during laparoscopic and robot-assisted partial nephrectomy: an assessment using Tc 99m-DTPA glomerular filtration rate. Eur Urol. 2010 Dec;58(6):900-5. doi: 10.1016/j.eururo.2010.08.044. Epub 2010 Sep 15.
- Background: PubMed 24791150Vasdev N, Poon AS, Gowrie-Mohan S, Lane T, Boustead G, Hanbury D, Adshead JM. The physiologic and anesthetic considerations in elderly patients undergoing robotic renal surgery. Rev Urol. 2014;16(1):1-9.
- Background: PubMed 18157662Dalfino L, Tullo L, Donadio I, Malcangi V, Brienza N. Intra-abdominal hypertension and acute renal failure in critically ill patients. Intensive Care Med. 2008 Apr;34(4):707-13. doi: 10.1007/s00134-007-0969-4. Epub 2007 Dec 19.
- Background: PubMed 21310818Mohmand H, Goldfarb S. Renal dysfunction associated with intra-abdominal hypertension and the abdominal compartment syndrome. J Am Soc Nephrol. 2011 Apr;22(4):615-21. doi: 10.1681/ASN.2010121222. Epub 2011 Feb 10.
- Background: PubMed 12375752Nguyen NT, Perez RV, Fleming N, Rivers R, Wolfe BM. Effect of prolonged pneumoperitoneum on intraoperative urine output during laparoscopic gastric bypass. J Am Coll Surg. 2002 Oct;195(4):476-83. doi: 10.1016/s1072-7515(02)01321-2.
- Background: PubMed 17003822Garg AX, Muirhead N, Knoll G, Yang RC, Prasad GV, Thiessen-Philbrook H, Rosas-Arellano MP, Housawi A, Boudville N; Donor Nephrectomy Outcomes Research (DONOR) Network. Proteinuria and reduced kidney function in living kidney donors: A systematic review, meta-analysis, and meta-regression. Kidney Int. 2006 Nov;70(10):1801-10. doi: 10.1038/sj.ki.5001819. Epub 2006 Sep 27.
- Background: PubMed 9010805Gomez-Anson B, Carrero-Lopez V, Diaz-Gonzalez R. Image-directed color Doppler ultrasound evaluation of the single kidney after unilateral nephrectomy in adults. J Clin Ultrasound. 1997 Jan;25(1):29-35. doi: 10.1002/(sici)1097-0096(199701)25:13.0.co;2-m.
- Background: PubMed 23031084Nekouei S, Ahmadnia H, Abedi M, Alamolhodaee MH, Abedi MS. Resistive index of the remaining kidney in allograft kidney donors. Exp Clin Transplant. 2012 Oct;10(5):454-7. doi: 10.6002/ect.2012.0054.
- Background: PubMed 12415336Lindberg F, Bergqvist D, Bjorck M, Rasmussen I. Renal hemodynamics during carbon dioxide pneumoperitoneum: an experimental study in pigs. Surg Endosc. 2003 Mar;17(3):480-4. doi: 10.1007/s00464-002-9044-y. Epub 2002 Nov 6.
- Background: PubMed 21507469Wiesenthal JD, Fazio LM, Perks AE, Blew BD, Mazer D, Hare G, Honey RJ, Pace KT. Effect of pneumoperitoneum on renal tissue oxygenation and blood flow in a rat model. Urology. 2011 Jun;77(6):1508.e9-15. doi: 10.1016/j.urology.2011.02.022. Epub 2011 Apr 19.
- Background: PubMed 12799887Zacherl J, Thein E, Stangl M, Feussner H, Bock S, Mittlbock M, Erhardt W, Siewert JR. The influence of periarterial papaverine application on intraoperative renal function and blood flow during laparoscopic donor nephrectomy in a pig model. Surg Endosc. 2003 Aug;17(8):1231-6. doi: 10.1007/s00464-002-8835-5. Epub 2003 Jun 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dita Aditianingsih, MD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumoperitoneum pressure in people with Healthy, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Syndecan-1 level from baseline (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219398, which also lists 122 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.