German Clinical Trials Register

Acronym/abbreviation of the study

pedACS concept study

URL of the study

No Entry

Brief summary in lay language

Many diseases - which cause an intensive care unit stay - lead to the development of organ and tissue swelling or fluid retention in the abdominal or thoracic cavity. Since the space in the abdomen is limited (especially in children), these processes may increase the pressure within the abdominal cavity, which can restrict blood flow to abdominal organs and thus impede their oxygen supply. As a consequence, organs may fall ill, which initially may not have led to the intensive care unit stay. Unfortunately, there are no clear external signs and changes associated with a high pressure in the abdomen which could be interpreted as a warning signal. However, the healing process of the affected patient can be delayed severely or even fail in the worst case. For this reason, we are looking for appropriate diagnostic methods that will help to identify an increased intra-abdominal pressure (IAP) in children early and reliably, without the need for unpleasant additional examinations. Different direct and indirect methods for the measurement of intra-abdominal pressures are available. In the present study we want to measure the IAP via feeding tubes and / or bladder catheters and / or abdominal drainage or dialysis catheters, respectively (depending on which of these catheters or probes are required anyway due to the underlying illness of the critical ill children). In addition, we will monitor the blood circulation of the whole body and several abdominal organs using different measure methods (including ultrasound-dilution technique to quantify the circulating blood volume per minute as a measure of total circulatory function (macrocirculation) and including color duplex sonographic examinations of all abdominal organs to estimate the microcirculation). Additionally, the oxygen supply to the organs can be monitored using (near) infrared spectroscopy through the skin (non-invasive). Therefore, additional probes are applied to the skin over the respective organ through which the measurement can be performed completely painless. In blood, urine and other body fluids, we will look for specific proteins and nucleic acids, which can be released at the earliest in cases of pressure-induced tissue or organ damage and may serve as early biomarkers. This will help to define the height of an individual harmful intra-abdominal hypertension and to accelerate the onset of an appropriate therapy.

Brief summary in scientific language

Almost every critically ill child is in danger to develop intra-abdominal hypertension (IAH) or abdominal compartment Syndrome (ACS) due to diseases concerning the abdominal cavity and abdominal organs or systemic inflammatory states. As a consequence, ACS is able to cause multiple organ failure and death. Three groups of factors complicate an adequate diagnosis and timely initiation of treatment in the presence or development of IAH and ACS. These include (1) limitations of the quantification of intra-abdominal pressures (IAP) including the rare acceptance for regular IAP measurements, (2) the lack of non-invasive examination methods for the monitoring of microcirculation and organ perfusion particularly under the suppressive influence of increased IAP, and (3) the hitherto fruitless search for laboratory early warning parameters (biomarkers), by which the transition to an IAP-induced organ dysfunction might be detected before the onset of an ischemia-triggered systemic inflammation and potentially irreversible vicious circle with multi-organ failure and death. The aim of this study is therefore (1) the validation of a continuous IAP measurement method via the stomach in children which might be superior to the intermittent bladder pressure measurements which is currently considered the standard method of IAP monitoring in pediatric patients. To this end, IAP will be measured using both direct and indirect methods (through the stomach and bladder) and the measurement results will be correlated against each other. (2) the establishment of the basis for the analysis duplexsonographischer findings dynamic Gewebeperfusionsmessung (DTPM; PixelFlux ®) and somatic near-infrared spectroscopy (NIRS) as a tool for non-invasive monitoring of the microcirculation parenchymatous organs under IAH / ACS and (3) the identification of laboratory chemical biomarkers to more timely detection of IAD-induced ischemia and organ damage (promising candidates: intestinal and hepatic fatty acid binding protein (IFABP, hFABP), citrulline and zonulin, various microRNA). The data obtained should contribute to early and reliable diagnosis critical limitations of the micro and macro circulation under IAH / ACS and thereby reduce the high morbidity and mortality.