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Intra-abdominal Pressure in Peritoneal Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811640
Recruitment Status : Completed
First Posted : June 23, 2016
Results First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition Peritoneal Dialysis
Intervention Other: Study Participants
Enrollment 12
Recruitment Details  
Pre-assignment Details Two patients had to be excluded from the analysis due to difficulties zeroing the Stryker pressure monitor at the time of surgery.
Arm/Group Title Study Participants
Hide Arm/Group Description

Adults with chronic kidney disease who will have a PD catheter inserted at the Ottawa Hospital

Study Participants: IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion

Period Title: Overall Study
Started 12
Completed 10
Not Completed 2
Reason Not Completed
Technology malfunction             2
Arm/Group Title Study Participants
Hide Arm/Group Description

Adults with chronic kidney disease who will have a PD catheter inserted at the Ottawa Hospital

Study Participants: IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  66.7%
>=65 years
4
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
53  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
3
  25.0%
Male
9
  75.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 12 participants
12
1.Primary Outcome
Title Intra-Abdominal Pressure (IAP)
Hide Description The Intra-Abdominal Pressure (IAP) measured with the Stryker monitor connected to the peritoneal dialysis (PD) catheter was compared with the insufflator pressures at of 15, 10, and 5 mm Hg.
Time Frame During laparoscopic surgery, up to 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
There is only 1 arm or group for this study. The study participants are adults with chronic kidney disease who had a PD catheter inserted at the Ottawa Hospital. During the insertion, IAP was observed and measured with a hand held Stryker Pressure Monitor and with the insufflator. These results were compared, and the average difference and the standard deviation between the two are reported.
Arm/Group Title Study Participants
Hide Arm/Group Description:

Adults with chronic kidney disease who will have a PD catheter inserted at the Ottawa Hospital

Study Participants: IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
15 mm Hg -0.5  (2.0)
10 mm Hg -0.2  (3.1)
5 mm Hg -1.2  (2.6)
Time Frame During laparoscopic surgery, up to 30 minutes
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Participants
Hide Arm/Group Description

Adults with chronic kidney disease who will have a PD catheter inserted at the Ottawa Hospital

Study Participants: IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion

All-Cause Mortality
Study Participants
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Serious Adverse Events
Study Participants
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Participants
Affected / at Risk (%)
Total   0/12 (0.00%) 

Technical problems with measurement leading to small sample size, and lack of a gold standard comparative may have affected our results.

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Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Deborah Zimmerman
Organization: Ottawa Hospital Research Institute
Phone: 613-738-8400 ext 81620
EMail: dzimmerman@toh.ca
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02811640    
Other Study ID Numbers: 20160377-01H
First Submitted: June 21, 2016
First Posted: June 23, 2016
Results First Submitted: September 16, 2020
Results First Posted: November 18, 2020
Last Update Posted: November 18, 2020