Clinical Research Directory

The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure

Systemic venous congestion is the primary therapeutic target of intravenous loop diuretics in patients admitted for acute heart failure (AHF). Despite their utility, a significant proportion of AHF patients are discharged with persistent clinical symptoms of congestion (residual congestion). Therefore, in recent years, there has been a growing focus on the use of tools (biomarkers, clinical ultrasound) that allow us to optimize diuretic treatment and thereby improve the prognosis of AHF patients. The objective is to analyze whether the strategy of guiding intravenous loop diuretic dosing based on intra-abdominal pressure(IAP) measurements and clinical ultrasound is superior to the conventional strategy employed in daily clinical practice. This study is a randomized, multicenter clinical trial involving consecutive patients admitted with a diagnosis of AHF in the Internal Medicine and Cardiology departments. Patients who meet the inclusion criteria, after signing informed consent, will be randomized into two groups: 1) Diuretic treatment guided by usual clinical practice and 2) Treatment guided by intra-abdominal pressure levels and clinical ultrasound (inferior vena cava and portal Doppler). This strategy will be maintained during the first 72 hours of admission, with a thorough analysis of congestion and diuretic response being conducted.

Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants

The goal of this clinical trial is to learn more about intestinal regional oxygen saturation measurements made with near-infrared spectroscopy and bladder pressure measurements in infants without risk of intraabdominal hypertension. The main question it aims to answer is if - in comparison to bladder pressure - the regional intestinal oxygen saturation measured with near-infrared spectroscopy is stable in the muscle-relaxed, intubated patients and the awake and non-sedated patient. In case of participation the bladder pressure and the regional intestinal oxygen saturation (measured with near-infrared spectroscopy) will each be measured once intraoperatively and once postoperatively. Patients included in this study will be undergoing an operation which necessitates muscle-relaxation, as well as an indwelling urinary catheter during the operation and for a short-time thereafter for other reasons than this study.

Correlation Between Intra-abdominal Pressure, Biomarkers of Bacterial Translocation and Intestinal Wall Damage

Main scientific hypotheses of the project: 1\. The level of intestinal microflora translocation markers and biomarkers of intestinal wall damage the in the blood serum correlates with the level of intra-abdominal pressure, regardless of the genesis of intra-abdominal hypertension. 2\. The critical levels of intestinal microflora translocation markers and biomarkers of the intestinal wall damage can be used for predicting an unfavorable outcome in the multiple organ dysfunction syndrome. 3\. The revealed critical level of intra-abdominal pressure is an additional prognostic sign in assessing the course of the multiple organ dysfunction syndrome. . Project objectives: 1. To evaluate the indicators of biomarkers of translocation of the intestinal microflora and biomarkers of the intestinal wall damage in the systemic circulation during the development and course of the syndrome of multiple organ dysfunction. Based on the obtained critical levels of markers of translocation of the intestinal microflora and markers of the intestinal wall damage, it will be possible to predict adverse outcomes in patients with multiple organ dysfunction syndrome. 2. To identify differences in the level of markers of bacterial translocation of the intestinal microflora and the level of markers of the intestinal wall damage in patients with intra-abdominal hypertension. In patients with multiple organ dysfunction syndrome, the levels of biomarkers of bacterial translocation of the intestinal microflora and biomarkers of intestinal wall damage in the blood serum correlate with intra-abdominal pressure indicators, regardless of the etiology of intra-abdominal hypertension. 3. Assess the impact of the level of intra-abdominal pressure on the development and course of the syndrome of multiple organ dysfunction. To assess the course of the syndrome of multiple organ dysfunction, an additional prognostic marker is the determination of the critical level of intra-abdominal pressure. 4. Determine the critical levels of biomarkers of intestinal microflora translocation and biomarkers of intestinal wall damage to predict the outcome of diseases accompanied by the development of multiple organ dysfunction syndrome. The obtained critical levels of biomarkers of translocation of the intestinal microflora and biomarkers of the intestinal wall damage will be significant indicators in the syndrome of multiple organ dysfunction for predicting an unfavorable outcome.

Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study

The open abdomen can occur as a result of various diseases. After infections of the abdomen, compartment syndromes or traumata, it is essential for survival (1). This condition of the open abdomen lasts from days to months. Within a very short time, the fascia and abdominal wall structures retract in such a way that direct abdominal closure is often impossible. In addition, there is a pronounced intraabdominal oedema, which additionally increases the space required by the abdominal organs. Therefore, it is clinically indispensable to increase the space of the intraabdominal organs in this life-threatening situation. After the laparotomy (opening of the abdomen) has been performed, it is therefore not closed. However, the natural traction on the abdominal wall, in particular on the fascia, the attached musculature as well as skin and subcutis, no longer exists in this situation. As a result, these structures retract over the period of the existing laparostoma. In the present study, the CE-certified medical device Fasciotens Abdomen will be used to prove the functionality of this device and the user feasibility. The basic principle of Fasciotens Abdomen is the ventrally directed pulling force on the two fascial edges via an external device with support on the thorax and pelvis. The possibility to apply a traction to the fascia from the moment of opening the abdomen without reducing the intraabdominal space is absolutely new and the rationale of this technique. The objective of this study is to prove the obvious prevention of fascial retraction through the Fasciotens Abdomen device.

Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry

The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.