Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001716257
Ethics application status
Approved
Date submitted
27/09/2018
Date registered
17/10/2018
Date last updated
17/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of pressure in abdominal cavity on visceral blood flow in children
Scientific title
Effect of intraabdominal hypertension on splanchnic blood flow in children
Secondary ID [1] 296191 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraabdominal hypertension 309824 0
Condition category
Condition code
Oral and Gastrointestinal 308616 308616 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 308733 308733 0 0
Diseases of the vasculature and circulation including the lymphatic system
Musculoskeletal 308789 308789 0 0
Other muscular and skeletal disorders
Cardiovascular 308790 308790 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intraabdominal pressure, diameter and time-average mean blood flow velocity of the superior mesenteric artery and portal vein were measured 4 times per day for 7 days in all children who have undergone appendicular peritonitis surgery.
Intervention code [1] 312516 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307579 0
Mean value of intraabdominal pressure (IAP). IAP was measured in the bladder through a Foley catheter in supine position after administration 1ml/kg (but not more 25 ml) of normal saline. The end of the catheter was connected to clear, open-ended plastic tubing. After stabilization period of 30-60 seconds at end-expiration the level of the water column above the midaxillary line reflected IAP.
Timepoint [1] 307579 0
Daily for 7 days 4 times per day
Primary outcome [2] 307679 0
Mean value of volumetric blood flow velocity (BF) in superior mesenteric artery and portal vein. These were calculated using by formula: BF = CSA•TAMV•60. where CSA is cross-sectional area (cm2) and TAMV (cm/sec) is time-average mean blood flow velocity of the superior mesenteric artery (SMA) and portal vein (PV). Parameters were measured just below the xiphoid process using Hitachi EUB-525 Plus ultrasound scanner with 3,5 MHz convex transducer in the B-mode with Doppler.
Timepoint [2] 307679 0
Daily for 7 days 4 times per day
Secondary outcome [1] 352636 0
nil known
Timepoint [1] 352636 0
nil known

Eligibility
Key inclusion criteria
Children with peritonitis. Parents` consent.
Minimum age
1 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of parents` consent

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2018
Date of last participant enrolment
Anticipated
Actual
1/09/2018
Date of last data collection
Anticipated
Actual
10/09/2018
Sample size
Target
100
Accrual to date
Final
94
Recruitment outside Australia
Country [1] 20875 0
Ukraine
State/province [1] 20875 0
Lviv region

Funding & Sponsors
Funding source category [1] 300781 0
University
Name [1] 300781 0
Danylo Galytsky Lviv National Medical University
Country [1] 300781 0
Ukraine
Primary sponsor type
University
Name
Danylo Galytsky Lviv National Medical University
Address
Pekarska st. 69. Lviv. 79010. Ukraine.
Country
Ukraine
Secondary sponsor category [1] 300329 0
Hospital
Name [1] 300329 0
Lviv Regional Children`s Clinic Hospital
Address [1] 300329 0
Lysenka 31. Lviv 79008. Ukraine.
Country [1] 300329 0
Ukraine

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301564 0
Lviv Regional Children’s Hospital Ethics Committee
Ethics committee address [1] 301564 0
Lysenka str. 31, Liviv 79008
Ethics committee country [1] 301564 0
Ukraine
Date submitted for ethics approval [1] 301564 0
04/01/2018
Approval date [1] 301564 0
10/01/2018
Ethics approval number [1] 301564 0
3-1-2018

Summary
Brief summary
Intraabdominal hypertension lead to multiple organ dysfunction syndrome (MODS). However, viscerae, such as intestines and liver are damaged first. Lot of experimental studies showed that an increase of intraabdominal pressure (IAP) more than 10 mm Hg leads to progressive splanchnic blood flow lowering and an IAP elevation above 20 mm Hg is followed by intestinal mucosa ischemia, bacterial translocation, sepsis and MODS.
Clinical data on the relationship between IAP and splanchnic blood flow in children is lacking.
Ninety four children who have undergone appendicular peritonitis surgery were enrolled in the study. IAP and splanchnic blood flow was measured 4 times per day in all children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87402 0
Dr Valentyna Perova-Sharonova
Address 87402 0
Lviv Regional Children's Clinic Hospital, Lysenka st. 31, Lviv 79008, Ukraine
Country 87402 0
Ukraine
Phone 87402 0
+380673971913
Fax 87402 0
Email 87402 0
[email protected]
Contact person for public queries
Name 87403 0
Dr Valentyna Perova-Sharonova
Address 87403 0
Lviv Regional Children's Clinic Hospital, Lysenka st. 31, Lviv 79008, Ukraine
Country 87403 0
Ukraine
Phone 87403 0
+380673971913
Fax 87403 0
Email 87403 0
[email protected]
Contact person for scientific queries
Name 87404 0
Dr Andrew Albokrinov
Address 87404 0
Lviv Regional Children's Clinic Hospital, Lysenka st. 31, Lviv 79008, Ukraine
Country 87404 0
Ukraine
Phone 87404 0
+380672867103
Fax 87404 0
+380322759467
Email 87404 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of intraabdominal hypertension on splanchnic blood flow in children with appendicular peritonitis.2021https://dx.doi.org/10.4103/joacp.JOACP_293_19
N.B. These documents automatically identified may not have been verified by the study sponsor.