Prospective observational study to optimize and simplify the diagnosis of pathologically increased intra-abdominal pressure in critically ill children

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00006556
• Date of registration: 12/09/2014
• Prospective Registration: Yes
• Primary sponsor: Medizinische Hochschule Hannover
• Public title: Prospective observational study to optimize and simplify the diagnosis of pathologically increased intra-abdominal pressure in critically ill children
• Scientific title: Prospective observational study to optimize and simplify the diagnosis of pathologically increased intra-abdominal pressure in critically ill children - pedACS concept study
• Date of first enrolment: 04/05/2015
• Target sample size: 150
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00006556
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: Prognosis

Countries of recruitment

Germany

Contacts

• Name: Torsten Kaussen
• Affiliation: Medizinische Hochschule HannoverZentrum für Kinder- und JugendmedizinKlinik für pädiatrische Kardiologie und Intensivmedizin

• Name: Torsten Kaussen
• Affiliation: Medizinische Hochschule HannoverZentrum für Kinder- und JugendmedizinKlinik für pädiatrische Kardiologie und Intensivmedizin

Key inclusion & exclusion criteria

Inclusion criteria: All term infants and pediatric patients between 0 and 18 years of life who are taken to the interdisciplinary pediatric intensive care unit of the Medical University of Hannover and who need anyway - due to their illness or treatment - an abdominal drainage (wound or ascites drainage, peritoneal dialysis catheter etc.) and a gastric tube and / or a urinary catheter might be included in this study. For this purpose, patients and parents are informed in detail about the nature, meaning and objectives of the study and must have expressly agreed to their participation and transmitted a written consent form before the start of measurements. Against the background of nasopharyngeal and esophagogastric proportions formerly preterms can not be included in the study before reaching the expected delivery date in cases of then newly emerging risk factors and new-onset intra-abdominal hypertension.
Preferably, IAP should be measured in children and adolescents at risk for the development of intra-abdominal hypertension (IAH). Related risk factors include all disease entities associated with a pathology and especially inflammation of the abdominal and retroperitoneal spaces or therein located organs and tissues (eg, peritonitis, perforation, pancreatitis, ileus, volvulus, necrotizing / infectious enterocolitis, hemorrhage, tumor / space-occupying processes). Abdominal wall closures (in cases of congenital abdominal wall or diaphragmatic hernia) and "large-for-size" organ transplants are considered "prototypes" of IAH-inducing diseases, since the intra-abdominal filling volume required for a tension-free abdominal closure is insufficient (especially in neonatal patients). Intra-parenchymal and cavitary fluid collections that are observed particularly in the context of capillary leak due to sepsis and systemic inflammation are the most common cause group for IAH and ACS in childhood [Beck 2001]. In addition, hypothermia, positive balance, (mass) transfusions, mechanical ventilation, hypotension and acidosis could be identified as general risk factors for the development of IAH and ACS [Holodinsky 2013, Malbrain 2013].

Exclusion criteria: Against the background of nasopharyngeal and esophagogastric size ratios preterm infants (Also excluded are all pediatric patients who have a disease entity of the nasopharynx and / or the upper gastrointestinal tract. These include in particular those children who need surgery or differentiated interventional as well as non-surgical therapies such as dilatation or radiation due to injury, disease or deformity in these areas or have already been operated or treated, respectively. In children and adolescents with a known, suspected or contemporaneous disturbance of the gastric muscle tone as well as following esophageal or gastric surgery (especially anastomosis in esophageal atresia, stomach pull-up, fundoplication or placement of percutaneous endoscopic gastrostomy) no reliable intra-gastric pressure measurement can be expected.
Children and young people with a known or suspected neurogenic bladder dysfunction can be included in the study; however, due to the imperfection of measured intra-vesical pressures bladder pressure measurements must be omitted. All other parameters can be determined, correlated and statistically analyzed.


Age minimum: 38 Pregnancy
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

R19.0
R10.0

Intra-abdominal and pelvic swelling, mass and lump

R10.0

Acute abdomen

R19.0

Intervention(s)

Group 1: All children and adolescents who are admitted to the interdisciplinary intensive care unit and whose characteristics are consistent with the inclusion criteria. The intra-abdominal pressure is measured directly and indirectly in each subject (via the stomach and via the urinary bladder). The resulting results are correlated with each other and the quality, sensitivity and reliability of the indirect measurement methods will be examined by comparison with direct pressure measures. In addition, micro- and macro-circulation will be monitored in all subjects using global hemodynamic measurement methods, PixelFlux and NIRS. Changes in perfusion and microcirculation are brought into relation with the respective IAP-levels and any mutual influences will be analyzed. Laboratory chemical standard parameters (such as blood count, transaminases, retention parameters, pancreatic enzymes, inflammatory markers) and blood gas analyses as well as the extent of medical assistance are recorded to detect the degree of organ dysfunction and systemic inflammation. Depending on all the above mentioned parameters different proteins and microRNA's are to be identified as potential biomarkers.

Primary Outcome(s)

Correlation of directly measured intra-abdominal pressures with indirect measuring methods (via the stomach and bladder) and assessment in terms of accuracy (goodness of fit), sensitivity and practicality. Using gastric tubes the IAP can be determined continuously; via the bladder or using direct accesses, however, the IAP can be examined only intermittently. The proposal provides for hourly documentation of continuous readings and a two-hourly collection and documentation of discontinuous IAP-values.

Secondary Outcome(s)

Investigation of the influence of different intra-abdominal pressures on global hemodynamics and microcirculation in critically ill children. In addition to established intensive care Parameters at least three times daily cardiac output and other volumetric parameters will be determined using the ultrasound dilution technique (macrocirculation). Duplex ultrasound studies of the microcirculation in parenchymal organs are also done three times a day, which later can be evaluated and quantied using the PixelFlux software. Using somatic optodes, tissue oxygen saturation in parenchymal organs will be continuously monitored with the help of near-infrared spectroscopy (NIRS). The results of NIRS determination will be compared with central venous saturations at least 4x daily . In addition to established laboratory chemical organ parameters, the Proteins zonulin and citrulline, as well as different fatty acid binding proteins and micro-RNAs are regularly determined to thereby establish new biomarkers for the early detection of IAP-induced organ and tissue damage.

Source(s) of Monetary Support

Medizinische Hochschule Hannover

Ethics review

Status: Approved
Approval date: 04/07/2014
Contact:

[e-mail]

Ethikkommission der Medizinischen Hochschule Hannover

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00006556#studyResults