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NCT ID: NCT06390605 Not yet recruiting - Critical Care Clinical Trials

a Ultrasonographic Measurement of Intra-abdominal Pressure

Start date: May 1, 2024
Phase:
Study type: Observational

Intra-abdominal pressure (IAP) refers to the stable pressure in a closed cavity. Its magnitude is determined by the compliance of the abdominal wall and the pressure of the abdominal cavity contents, and it increases with inhalation and decreases with exhalation. Due to fluid retention, organ failure, use of ventilators, and other reasons, critically ill patients have higher intra-abdominal pressure, ranging from 5-7mmHg. However, the expansion capacity of the peritoneal cavity is limited. As the internal pressure rises, when the intra-abdominal pressure rises above 12 mmHg, intra-abdominal hypertension (IAH) occurs. Elevated IAP has harmful physiological effects on almost all organ systems, including the central nervous system, cardiovascular, respiratory, kidney, gastrointestinal, and liver systems. When IAP continues to rise and is accompanied by new or progressive organ failure, it develops into abdominal compartment syndrome (ACS), which is the end-stage manifestation of severe IAH. Currently, there are various methods for measuring intra-abdominal pressure, including direct intraperitoneal measurement, transbladder measurement, gastric measurement, superior and inferior vena cava measurement, rectal measurement, and noninvasive measurement. However, the most commonly used clinical method is indirect transbladder measurement. This technique is clinically feasible and accurate, making it the internationally recognized "gold standard" for intra-abdominal pressure monitoring. Nevertheless, it has been reported that the accuracy and reproducibility of intra-bladder pressure measurements can be influenced by many factors, resulting in a large coefficient of variation in intra-abdominal pressure measurements obtained by this method. Additionally, the indirect transbladder measurement technique is cumbersome, discontinuous, and carries a potential risk of infection. Therefore, the development of noninvasive, safe, and reliable IAP monitoring techniques or methods has garnered widespread attention from scholars both domestically and internationally. This study measures IAP using a combination of ultrasound and external pressure application. By comparing it with the gold standard, intra-bladder pressure measurement, we observe the accuracy and reliability of this measurement method. The aim is to provide a noninvasive, fast, accurate, and reliable method for measuring intra-abdominal pressure in critically ill patients.

NCT ID: NCT06374823 Not yet recruiting - Critical Care Clinical Trials

Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke

MERIT
Start date: May 2024
Phase: Phase 4
Study type: Interventional

Normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs during clinical practice. However, the chloride concentration of normal saline (154mmol/L) is much higher than human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. In contrast, the concentrations of Multiple electrolytes II is more similar to those of plasma and is considered to be a better fluid choice than normal saline.

NCT ID: NCT06133504 Not yet recruiting - Critical Illness Clinical Trials

Early Multimodal Therapy and Mechanical Ventilation

Start date: June 2024
Phase: N/A
Study type: Interventional

To assess the association between early multimodal therapy and the duration of invasive mechanical ventilation in the Intensive Care Unit at Fundación Santa Fe de Bogotá.

NCT ID: NCT05960994 Not yet recruiting - Telemedicine Clinical Trials

Evaluation of the Clinical Impact of Different Telemedicine Practices in Intensive Care Units

Telescope_2
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to assess whether an intervention package via telemedicine consisting of daily multidisciplinary rounds with a specialist in intensive care medicine, an intervention package provided by a specialized multiprofessional team (nursing, physical therapy and clinical pharmacy) and a management intervention package, focused on quality and safety, reduces the length of stay in ICU patients in Brazil. Our hypothesis is that the intervention package via telemedicine has the potential to decrease the length of stay in ICU patients in Brazil. The study provides for the implementation of three interventions in association via telemedicine. - Daily multidisciplinary rounds conducted by a physician specialized in intensive care medicine - Intervention package by specialized multidisciplinary team (nursing, physiotherapy and clinical pharmacy). - Management intervention package (quality and safety). The main questions it aims to answer are: - Length of stay in ICU, measured in days, considering the time interval between admission to the ICU and the moment of physical transfer of the patient to another hospital admission area or external transfer. - ICU mortality. - Mechanical ventilation free time at 28 days. - Ventilator-associated events. - Patient Mobilization Density. - Standard resource use. - Standardized mortality rate.

NCT ID: NCT05593380 Not yet recruiting - Critical Care Clinical Trials

The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH

BIATICH
Start date: October 15, 2022
Phase: N/A
Study type: Interventional

Spontaneous cerebral hemorrhage (SICH) is a hemorrhage caused by the rupture of a blood vessel within the brain parenchyma that is non-traumatic. Its rapid onset and dangerous condition seriously threaten human health; it accounts for about 15% of strokes and 50% of stroke-related mortality. Hunan Province is recognized as one of the high incidence areas of cerebral hemorrhage in the world; according to statistics, the direct economic loss caused by cerebral hemorrhage in Hunan Province is more than 1 billion yuan per year, which should be paid great attention. A 30-day follow-up study of large-volume cerebral hemorrhage (defined as supratentorial hemorrhage greater than 30 ml, infratentorial greater than 5 ml, and thalamus and cerebellum greater than 15 ml) found that the morbidity and mortality rate of ICH with hemorrhage of 30-60 ml was as high as 44-74%, while the morbidity and mortality rate of ICH with hemorrhage of <30 ml was 19% and that of >60 ml was 91%. According to studies, the occurrence of hematoma occupancy and malignant cerebral edema in large-volume cerebral hemorrhage can lead to secondary malignant intracranial pressure elevation and subsequent secondary brain injury, which are the main factors of high morbidity and mortality and poor prognosis in patients with large-volume cerebral hemorrhage. Clinical monitoring and management is the key to treatment, and despite aggressive surgical treatment and anti-brain edema therapy, a large number of patients progress to malignant brain edema disease, leading to poor outcomes. Therefore, this project intends to conduct a multicenter clinical trial of non-invasive monitoring of large volume cerebral hemorrhage on the curtain in the Hunan region to explore the impact of non-invasive brain edema monitoring management based on bioelectrical impedance technology on patient prognosis; and to explore early biomarkers of malignant brain edema through metabolomic analysis and the mechanism of malignant brain edema occurrence through multi-omic analysis to provide data support for the clinical treatment application of malignant brain edema.

NCT ID: NCT05386303 Not yet recruiting - Critical Care Clinical Trials

Quantitative Pupillometry

HYDRO-NiP
Start date: May 31, 2022
Phase:
Study type: Observational

The aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain.

NCT ID: NCT05260710 Not yet recruiting - Telemedicine Clinical Trials

Evaluation of the Impact of Telemedicine in Pediatric Intensive Care Units

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

This study will be a cluster randomized controlled trial to assess the impact of telemedicine in Pediatric Intensive Care Units (PICU), through daily tele-rounds with a board certified physician and educational activities, in improving clinical-assistance indicators, as well as reducing the length of stay in the PICU.

NCT ID: NCT04859855 Not yet recruiting - Surgery Clinical Trials

Transfusional Trigger in Post-operative Oncologic Patients in Critical Care

Start date: May 2021
Phase: N/A
Study type: Interventional

Transfusional practices evolved significantly over the last decades, but there are still important controversies regarding triggers that should be adopted in different clinical scenarios. Most international guidelines recommend using a hemoglobin (Hb) level around 7,0-8,0g/dL as the value to prompt a transfusion of red blood cell concentrates (RBC). Critical care patients usually are in a hyperdynamic state, working with an elevated cardiac output and compromised organ function. In these patients, the dependency on the arterial content of oxygen is greater, making lower Hb levels more associated with organ disfunction and compromised homeostasis. With this study the investigators hope to help clinicians to make decisions regarding transfusion of RBCs in critical surgical patients, establishing a transfusional trigger, without exposing patients to unnecessary additional risks, in the scenario involving patients with cancer, in post-operative care. This is a prospective, randomized, controlled, interventional trial, with the aim of evaluating the impact of restrictive versus liberal transfusional strategy on mortality and severe clinical complications in post-operative oncologic critically ill patients. The primary outcome is mortality in 30 days. The interventions consist in transfusion of RBCs according to the allocation to a liberal or restrictive transfusional strategy. In the restrictive strategy arm patients will receive transfusion of RBCs if the Hb falls to a level equal to or below 7,0g/dL. In the liberal strategy arm patients will receive transfusions if Hb level is below or equal to 9,0g/dL. In both arms patients should receive only one unit of RBC per time, with measurement of Hb level after three hours to evaluate the need for additional units. The strategy should be maintained during intensive care unit (ICU) stay for a maximum of 90 days. In case of a permanence in the ICU for a period longer than 90 days, or if the patient is discharged from the ICU, the transfusional support will be determined by the assisting physicians, independently of the allocated study arm. If the patient returns to the ICU during the 90 days of randomization, then he should go back to receiving transfusions according to the liberal or restrictive strategy in use previously in the ICU.

NCT ID: NCT04311190 Not yet recruiting - Nurse's Role Clinical Trials

Family Engagement in Intensive Care Unit

FENICE
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

We hypothesized that engaging families in the care of critically ill patients could improve outcome both at the family and at the patient levels. Thus, the aim of this project is to assess the effects of a family engagement program on family members' satisfaction and on patients' well-being and quality of life.

NCT ID: NCT04215965 Not yet recruiting - Critical Care Clinical Trials

Efficacy and Safety of a Citrate-based Anticoagulation With Calcium-free Phosphate-containing Fluid in Renal Replacement Therapy

Phosphorus
Start date: May 2, 2020
Phase: Phase 4
Study type: Interventional

In the present prospective multicenter RCT we will evaluate the effects on efficacy, acid-base status and serum phosphate levels of a new RCA protocol for Continuous Venovenous Hemodiafiltration (CVVHDF) using an 18 mmol/l citrate solution in combination with a calcium-free phosphate-containing solution, acting as dialysate and replacement fluid. The new protocol will be introduced with the following targets: a) to refine buffers balance of a previously adopted RCA protocol for Continuous Venovenous Hemofiltration (CVVH), based on a 18 mmol/l citrate solution (Regiocit) combined with calcium and phosphate-free dialysate fluid (PrismOcal B22) and a conventional phosphate-containing replacement fluid (Phoxilium) to prevent CRRT-related phosphate depletion