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Critical Illness clinical trials

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NCT ID: NCT06128655 Not yet recruiting - Critical Illness Clinical Trials

Developing and Testing a Nurse-Led Technology-Enhanced Family Engagement Program

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

Family engagement in care for ICU patients is essential to ensure patient-centered clinical outcomes such as reducing ICU length of stay (LOS) by about a day, and hospital LOS from 3.78 days to 2.29 days. It also lowers patient's stress and anxiety, improves orientation, and detection, lowers the prevalence and duration of delirium; enhances patients' and families' satisfaction and experience with care and helps with patients' recovery. This practice has not been universally implemented due to issues with lack of transportation for family members to the hospital, time conflict with work, and clinicians' fear of engaging family. Family-centered care in the ICU remains an inconsistent practice and an understudied area of nursing science. Family-centered care in the ICU remains an inconsistent practice and an understudied area of nursing science. The purpose of this proposed study is to determine the feasibility of conducting a randomized controlled trial (RCT) to implement and test the impact of a Nurse-Led-Technology-EnhanCed Family Engagement Program (Nurse-TECH-Family) on the primary outcome of ICU LOS, and secondary outcome of reducing stress and improving quality of life and well-being among critically ill patients' families. We propose a pilot two-group RCT to examine the feasibility and preliminary effects of NURSE-TECH-Family program on 30 family members in the ICU. This study will be conducted at the Cooper University Health Care Medical Intensive Care Unit. Prior to conducting the RCT, we will involve a focus group of eight healthcare providers to understand healthcare providers' perceptions of the intervention and the project. The specific aims of this RCT are to (1) Assess the feasibility and acceptability of NURSE-TECH-Family program and obtain data on family stress, mental and physical health symptoms, and quality of life of family members. (2) Provide preliminary data for estimation of the effects of NURSE-TECH-Family program on family stress, mental and physical health symptoms, and quality of life post-program compared to a control group who will receive the current standard care. (3) Explore the effects of NURSE-TECH-Family on LOS and satisfaction based on Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores at post-program compared to a control group who will receive the current standard care.

NCT ID: NCT06120660 Recruiting - Sedation Clinical Trials

Musical Intervention on Stress Effects in Critically Ill Patients

Start date: October 14, 2023
Phase: N/A
Study type: Interventional

Aim: To evaluate the effects of a musical intervention on serum cortisol, prolactin, interleukin-6 levels and physiological parameters in sedated patients undergoing invasive mechanical ventilation.

NCT ID: NCT06119711 Active, not recruiting - Malnutrition Clinical Trials

Micronutrient Levels and Nutritional Status in Critical Illness

NUTRI-ICU
Start date: May 8, 2023
Phase:
Study type: Observational

Rationale: A significant proportion of patients admitted to the Intensive Care Unit (ICU) is unable to fully recover, even when the initial cause of their illness has been treated. Inadequate dietary intake prior to admission and during the recovery phase may leave patients in a frail physical state, limiting rehabilitation potential. Commonly used methods to assess nutritional intake and nutritional status are highly impacted by various disease-related confounders and reporting bias. We hypothesise that a combined assessment of biomarkers in plasma and urine may provide a more accurate overview of nutritional status at ICU-admission. Objective: Main: Assess nutrition-related biomarkers in plasma and urine samples at ICU admission Secondary: Identify the number of micronutrient deficiencies at ICU admission Compare biomarker profile and dietary intake of short and long-stay ICU patients at baseline Compare subjective dietary intake, nutritional status and muscle thickness between patients with and without micronutrient deficiencies at baseline Study design: Observational study Study population: Adult patients admitted to the ICU. Two groups will be recruited: patients with a short length of stay (<48 hours) and patients with a longer length of stay (≥48 hours). Main study parameters: Biomarker status in blood and urine at ICU admission. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In addition to standard care ICU treatment, the following measurements will be performed: - Within 24 hours after admission blood and urine samples will be collected from existing venous line and urinary catheter - Within 72 hours an ultrasound measurement of the upper leg will be performed. - During ICU stay, when the patient is capable to do so, they will be asked to complete a retrospective dietary intake assessment. The risks and negative effects of these tests are limited. However, this study asks for a time investment and physical and mental effort of the patients.

NCT ID: NCT06117345 Enrolling by invitation - Critical Illness Clinical Trials

Enhancing Parent/Caregiver Engagement in the Pediatric Intensive Care Unit (PICU): A PICU Journal

PICUJournal
Start date: May 15, 2024
Phase: N/A
Study type: Interventional

Admission to the pediatric intensive care unit (PICU) is well-recognized to be extremely distressing and stressful for the patient and family. As medical research and technology have advanced more and more children in the PICU are surviving, however in turn incurring new and persistent impairments across physical, cognitive, emotional, and social domains of health. This phenomenon is often referred to as post-intensive care syndrome (PICS). These impairments not only impact the patient but parents have also been found to have poor emotional health outcomes following discharge from the PICU. Consistently, parents/caregivers of children admitted to the PICU report their primary concerns to be 1) the overwhelming physical environment of the PICU, 2) uncertainty about the child's survivorship and outcomes, 3) relationships and communication with staff, and 4) feeling helpless. Additionally, research has shown that caregiver-perceived stress during the child's hospitalization positively predicts post-traumatic stress three months after discharge for parents/caregivers (Nelson et al., 2019), which may translate into higher risk and duration of post-traumatic stress in their children. Therefore, providing an in-hospital outlet such as a "PICU Journal" for patients and families to express their subjective experiences may help bridge the gap between perception and reality as a means of buffering against post-traumatic responses. Conceptually, a semi-structured journal intervention may integrate the therapeutic aspects of journaling while also providing pertinent information and serving as an advocacy and communication tool. Prior research has demonstrated the use of a "PICU Journal" is feasible for implementation and has been well-received by families of children in the PICU (Herrup et al., 2019). Therefore, the aims of this mixed-method study are to 1) examine the relationship between this journaling intervention and the perceived stress, care engagement, symptoms of anxiety, and depression, and the development of PICS in parents of children hospitalized in the PICU, and 2) examine the relationship between parent participation in this intervention and the development of PICS-p in children, and 3) assess the feasibility of this intervention from key stakeholders.

NCT ID: NCT06115863 Not yet recruiting - Delirium Clinical Trials

Effect of Early Cognitive Stimulation Interventions on Delirium and Cognitive Functions Among Critically Ill Patients

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

Delirium is an acute change in attention and awareness that develops over a relatively short time interval and associated with additional cognitive deficits such as memory deficit, disorientation, or perceptual disturbances. Delirium negative impact has been widely documented in the medical literature. It has been associated with increased mortality and morbidity, longer hospital stays, increase health care costs, and a longer duration of MV. Delirium in the ICU can be prevented and treated with a combination of pharmaceutical and non-pharmaceutical interventions. Cognitive interventions, as part of a delirium prevention strategy, are specific therapies focusing on the domains of cognitive functioning impacted by delirium such as orientation, attention, registration, recall and language. Cognitive stimulation interventions such as orienting patients to the date, time and place, visual and auditory stimulations that focused on specific domains (orientation and registration). In addition, cognitive stimulation included cognitive training and stimulation exercises that focus on specific domains (attention, language, recall, and registration) such as analyzing exercise, recalling exercise, and cognitive-training exercises by using mobile applications . The involvement of family members in the cognitive stimulation of critically ill patients is an underutilized resource that may benefit patients as well as gain a sense of control and purpose.

NCT ID: NCT06115044 Active, not recruiting - Critical Illness Clinical Trials

The DINE-Normal Proof-of-concept Study

Start date: December 27, 2023
Phase: N/A
Study type: Interventional

Overarching hypothesis In critically ill adults enteral feeding in a diurnal intermittent pattern improves patient centred outcomes. Research questions for this study Are the same derangements in metabolic and hormonal function observed in healthy volunteers when fed continuously via a nasogastric tube observed in critically ill patients and can those derangements be mitigated by intermittent diurnal feeding? Aim of this study Assess the effect of an enteral nutrition regimen mimicking the usual diurnal meal pattern on hormonal profile and metabolism in critically ill adults. This will generate novel and important proof of concept data and support progression to a clinical trial integrating investigation of physiological responses and patient centred outcomes. Objectives of this study Laboratory: Characterise patterns of hormone, lipid and metabolite response to intermittent diurnal feeding in critically ill adults. Clinical: assess feasibility, tolerability (vomiting and gastric residual volume) and efficacy (calorie delivery) of intermittent diurnal feeding in critically ill adults.

NCT ID: NCT06113601 Not yet recruiting - Critical Illness Clinical Trials

Assessment of Admission to the ICU of Onco-hematological Patients.

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

Multicenter, observational and prospective study.

NCT ID: NCT06113393 Not yet recruiting - Critical Illness Clinical Trials

The Effects of Different Gastric Residual Volume Thresholds for Holding Feeding in Internal Medicine.

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

This is a randomized control trial with a parallel design. Eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the GRV reaches 200 mL, and an experimental group will hold tube feeding when the GRV reaches 300 mL. Enteral feeding will be administered according to the study flow chart.

NCT ID: NCT06109740 Completed - Critical Illness Clinical Trials

Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit

Start date: October 2008
Phase: N/A
Study type: Interventional

The goal of this prospective trial is to learn about lactobacillus use in critically ill pediatric patients. The main question[s] it aims to answer are: - Is lactobacillus GG effective in preventing antibiotic associated diarrhea in the PICU - Is lactobacillus safe in critically ill pediatric patients Participants will be randomized to lactobacillus GG vs placebo while on antibiotics If there is a comparison group: Researchers will compare lactobacillus GG to see if it prevents antibiotic associated diarrhea.

NCT ID: NCT06109142 Not yet recruiting - Clinical trials for Critically Ill Patients

Clearance of Vasoactive Metabolites With Blood Purification

VITAL
Start date: April 1, 2024
Phase:
Study type: Observational

Extracorporeal blood purification is a supportive therapy in the management of patients with sepsis or vasoplegic shock. The pathophysiology of sepsis is based on an inappropriate host response to infection. Certain medical devices with higher adsorption capacity make it possible to limit this inappropriate response and could thus improve the hemodynamics of patients in septic or vasoplegic shock. The preliminary experience of the investigators from clinical data of vasopressor withdrawal in pediatric patients treated with oXiris shows a 50% reduction in the vasopressor score, Vaso Inotropic Score (VIS), for 40% of patients within 24 hours following the start of treatment. Similar results were found in adult patients treated for severe COVID-19 or vasoplegic shock by the other centers participating in the study. Cytokine purification is an important physiological effect of purification membranes. However, this may not fully explain the rapid hemodynamic improvement of patients treated with an oXiris membrane. The role of angiotensin metabolites (Ang 1-5, 1-7, 1-9) in the systemic vascular tone of patients has been recently discussed. The administration of angiotensin 2 in vasoplegic shock in adults helps correct hypotension. In the group of patients with increased renin, this treatment was associated with a reduction in mortality. Indeed, increased renin associated with dysfunction of Angiotensin Converting Enzyme (ACE) leads to an accumulation of Angiotensin 1 which degrades to Ang 1-7. The hypothesis f the investigators is that the concentration of Ang 1 and Ang 1-7 is elevated in cases of vasoplegic shock and that the clearance of these vasodilator peptides by blood purification is associated with clinical improvement.