Clinical trials

Post-thoracotomy pain syndrome (PTPS) is a prevalent complication that significantly impacts patients' quality of life, with reported incidence ranging from 25% to 90%. This study evaluated the effectiveness of continuous erector spinae plane (ESP) block compared to thoracic epidural analgesia (TEA), the current gold standard, in preventing PTPS. Our goal was to compare the incidence of PTPS between patients who received ESP block and those who underwent TEA. Additional goals included assessing postoperative pain levels, analgesic consumption, and complications related to the anesthesia techniques.

One of the significant challenges in the care of critically ill patients in the intensive care unit is the assessment of hemodynamically unstable patients (shock states). The treating team uses data such as heart rate, arterial blood pressure, physical examination findings, etc. to assess the patient's cardiac output, peripheral vascular resistance, filling pressures and volumes, and vascular tone. These assessments are essential to assess the cause of shock (cardiac cause, hypovolemia, sepsis, etc.), but in many situations they are not easy to perform and require extensive knowledge and experience. Assessing the hemodynamic status of a critically ill patient based on dynamic mechanical models may be a good option for more accurate assessment of complex patients. Such a model is, for example, the iCVS model: it is a relatively simple, mechanical-dynamic model that can be used to understand complex cardiovascular conditions. This model requires only age and weight as initial data, and as dynamic data the model requires only an arterial blood pressure (AR) curve and a central venous pressure (CVP) curve. The model is based on the shape of the above curves for the purpose of analyzing the cardiovascular status of the patient. The model is suitable for both adults and children, although most of the work to date has been among pediatric intensive care patients.

Taking blood cultures is an important and very common procedure in intensive care units due to the high incidence of sepsis and the need for rapid and accurate identification of bacteremia. However, despite the importance of taking a sufficient volume of blood for the purpose of identifying bacterial growth in the blood, the average blood volume in blood cultures at our institution ranges from 3.5-4 ml per bottle (where the desired volume is 10 ml). Taking an insufficient amount of blood reduces the ability of the bacteriological laboratory to detect bacterial growth and thus may lead to a delay or missed diagnosis of bacteremia, identification of the pathogen, and adjustment of appropriate treatment according to sensitivities. In intensive care units, most patients are monitored using an arterial catheter, which allows for frequent blood tests without the need to puncture the patient. Following recently published studies that showed that there is no significant difference in the incidence of contamination when taking blood cultures from an arterial catheter compared to a peripheral vein puncture, and in order to improve our ability to identify bacteremia, it was decided to implement a new protocol in the General Intensive Care Unit that includes taking blood cultures from an arterial catheter. According to the new protocol, it was decided that when taking blood cultures from a patient with an arterial catheter, one pair of cultures should be taken from the arterial catheter and another pair from a peripheral vein puncture. In this study, we would like to examine the contamination rate of blood cultures, the identification of true bacteremia, and the collection of appropriate blood volume and number of blood specimens taken in patients hospitalized in the General Intensive Care Unit at our institution, while analyzing differences between the period before the implementation of the new protocol and the period after the implementation, and differences between cultures taken from an arterial catheter and from a peripheral vein puncture.

Tracheostomy is one of the most common procedures in intensive care units. Post-tracheostomy increased body temperature within 24 hours is common. However, frequently sepsis workup is performed along with initiation of broad spectrum antibiotic therapy. We will investigate the incidence of post tracheostomy fever and whether retrospectively the increased temperature indicated development of sepsis or not. The study is retrospective and will be based on data collection.

In recent years, with an increase in the frequency of CT examinations, there has also been an increase in the random discovery of pulmonary emboli, often small, as part of examinations performed for other indications. Most of the literature so far deals with the discovery of such findings mainly in oncological patients, and there is relatively little information regarding the frequency of such random discovery in other patient populations. Specifically in the intensive care patient population, we have not yet found any study that examined the detection rates of these findings. Also, there is no consensus regarding how these random findings should be treated from a therapeutic point of view (whether to start treatment with full anticoagulation, and if so, for what period of time). Random pulmonary embolism is often discovered as part of a CT scan done to assess acute lung disease or lung cancer staging. In a study done in oncology patients, 385 chest CT examinations were examined, with a random discovery of pulmonary emboli at a rate of 2.6% . A larger analysis of 8 studies involving 8491 cancer patients found a slightly higher incidence of 3.6%. We would like to check the rate of pulmonary emboli that were randomly discovered in chest CT examinations performed in the intensive care unit for other indications, and the consequences of discoveries - ie starting anti-coagulant treatment and whether there were any complications for starting such treatment (bleeding).

Tracheostomy is one of the most common procedures in the intensive care unit in patients who need prolonged invasive mechanical ventilation. There is controversy in the literature regarding the ideal timing for performing tracheostomy in critically ill patients. Early tracheostomy may be associated with a decrease in ventilation days and hospitalization. We would like to investigate whether in ventilated patients with Guillain Barre syndrome, early tracheostomy will be associated with decreased ventilation days, decreased mortality and shorter hospital and ICU length of stay.

Vitamin C (ascorbic acid) is a water-soluble vitamin with antioxidant properties. Previous studies showed that the administration of vitamin C was associated with decreased triglyceride (TG) levels in ambulatory patients, especially in patients with type 2 diabetes. The decrease in TG level was more significant the younger the patient's age (less than 52.8 years), the longer the administration of vitamin C lasted (over 12 weeks) and the higher the daily dose was (over 1 gram per day) (2). However, we did not find any studies that examined the relationship between administration of vitamin C and lowering of TG level in critical patients in intensive care. High TG levels are often found in these patients, secondary to sepsis, administration of propofol by continuous infusion, administration of TPN, pancreatitis, liver failure and chronic dyslipidemia, diabetes and chronic renal failure. High TG levels in these patients may cause pancreatitis secondary to elevated TG, and we take several actions to lower TG levels in the unit when they exceed 500 mg per dL in order to avoid these complications. The actions taken include starting treatment with fibrates and/or statins, giving high-dose insulin, stopping the propofol drip and changing it to another hypnotic drug (usually midazolam), and giving fat-free TPN instead of fat-containing TPN. There are of course disadvantages to these interventions, such as drug interactions, longer clearance time and higher incidence of delirium when giving midazolam compared to propofol, hypoglycemia when giving a continuous insulin drip in high doses and giving a lower amount of calories to a patient who will receive TPN without lipids. There are many studies that examined the administration of vitamin C to patients in intensive care, especially patients with sepsis, with varied but inconclusive results. A recently published meta-analysis found a reduction in mortality among critical intensive care patients treated with intravenous vitamin C, especially in the subgroup of critically ill patients with a high risk of in-hospital mortality. The drug was found to be safe for use among patients in intensive care. In these patients in the various studies, vitamin C treatment was given intravenously in different doses, with most patients receiving a dose of 6 grams per day for 3-5 days. In light of a trend about five years ago that showed an improvement in survival among septic patients in intensive care who were treated with intravenous vitamin C as monotherapy, or in combination with steroids and/or intravenous thiamine, also in the intensive care unit at our institution (as well as in other hospitals) we started giving this treatment, at the recommended dose of 6 grams per day for 3-5 days. Over time, new studies did not find clear benefits for this treatment, so we gradually stopped giving it. However, if indeed vitamin C can contribute to a significant decrease in TG levels in patients in intensive care, there may be a point in administering it to a group of patients with high TG levels, in order to reduce complications associated with a high TG level and/or treatment to reduce it.

Hypotension is a common side-effect of general anesthesia induction and is related to adverse outcomes including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury.Half of all the patients were fluid-responsive, pointing to volume status as a significant risk factor. Ultrasound measurements of inferior vena cava (IVC) diameter with respiration, including the maximal diameter of the IVC (dIVCmax) at the end of expiration during spontaneous respiration and the collapsibility index (CI), have been recommended as rapid and noninvasive methods for estimating volume status. In attempt to prevent hypotension after spinal anesthesia induction, Ondansetron, a serotonin receptor antagonist, has been used effectively . Research Question Can preoperative IVC-US guided fluid optimization and intravenous ondansetron reduce the incidence of general anesthesia-induced hypotension in adult patients undergoing elective non-cardiac non-obstetric surgery?

Acute kidney injury is common among ICU-admitted patients, and is associated with increased morbidity and mortality. Early recognition is essential to prevent complications. In this study we aim to examine whether strict monitoring of urine output may reduce the incidence of acute kidney injury, allow for less positive fluid balance and reduce the clinical symptoms of fluid overload in ICU patients. Currently we monitor urine output using a Urinometer, with manual recording. From June 2022 we will begin routine use of an automated urine monitoring system in the ICU and test its effect on the parameters listed above. We will conduct a before-after retrospective intervention. The group of patients in whom the automated system will be used, from June 2022 to January 2024, will be the study group. The patients admitted to the ICU in the period between January 2021 and June 2022 will be the control group. We will include patients aged 18-100, who were admitted to the General Intensive Care Unit in Meir Medical Center from January 2021 to January 2024, and had admission time longer than 48 hours. Patients without a urinary catheter will not be included. The study will be conducted in the format of observational data collection from hospital files and computerized systems (Metavision system and Chameleon system). We estimate that we will include about 900 patients in the study group and about 900 in the control group. All demographic and inpatient data will be statistically examined by a qualified statistician depending on the type of data.

Intrathecal drug delivery systems (IDDS) are effective for managing chronic pain by delivering medications directly into the cerebrospinal fluid. Morphine, a primary opioid used in these systems, must remain chemically stable and sterile over prolonged periods to ensure patient safety and therapeutic efficacy . Previous studies have evaluated morphine stability in vitro under simulated conditions , indicating minimal degradation in saline over time . However, there is limited real-world data regarding the residual morphine in pump reservoirs after extended use . This study seeks to bridge this gap by analyzing morphine aspirated from intrathecal pumps during routine refills in a clinical setting, while comparing it to in vitro samples taken in the clinic .. Objectives Primary Objective: To determine the chemical stability of morphine in intrathecal pump reservoirs over a 3 to 6-month period of clinical use. Secondary Objective: To assess the sterility of residual morphine and evaluate any microbial contamination.

The study "Doppler Flow in Tubal Ectopic Pregnancy as a Predictor of Treatment Success: Conservative and MTX Therapy" aims to evaluate the role of Doppler ultrasound parameters (RI, PI, and PSV) in predicting treatment success for tubal ectopic pregnancies. Ectopic pregnancies, affecting \~2% of all pregnancies (98% in fallopian tubes), pose significant risks, including rupture and maternal mortality. Diagnosis is typically achieved via transvaginal ultrasound, with Doppler imaging enhancing accuracy by detecting characteristic vascular patterns. Management options include conservative monitoring, methotrexate (MTX) therapy, or surgery, based on clinical stability, β-hCG levels, and ultrasound findings. While β-hCG levels are a known predictor of MTX treatment failure, there is no consensus on an optimal threshold. Prior research suggests increased vascularization on Doppler ultrasound may correlate with higher MTX success rates. This prospective study will involve 60 women aged 18-45 with stable, unruptured tubal ectopic pregnancies. It will assess Doppler parameters and other clinical factors as predictors of treatment success. Findings aim to address gaps in the literature and improve management strategies for tubal ectopic pregnancies.

The goal of this interventional study is to evaluate the effectiveness of membrane stripping in cervical ripening compared to double balloon catheter induction. The study population consists of women undergoing labor induction. The main questions it aims to answer are: 1. Is membrane stripping as effective as double balloon catheter induction in cervical ripening? 2. What is the influence of membrane stripping on the time required for cervical ripening, delivery duration, and maternal and fetal outcomes compared to balloon induction.

The goal of this clinical trial is to learn whether the surgical approach used for hemiarthroplasty can improve clinical and functional outcomes in adults with displaced femoral neck fractures. The main questions it aims to answer are: * Does the direct anterior approach (DAA) result in superior postoperative functional recovery compared with the direct lateral approach (DLA)? * Are mortality, complications, hospital utilization, and readmission rates different between the two surgical approaches? Researchers will compare hemiarthroplasty performed using the direct anterior approach to hemiarthroplasty performed using the direct lateral approach to determine whether surgical approach influences postoperative function, complications, and survival. Participants will: * Undergo hemiarthroplasty for displaced femoral neck fracture using a randomly assigned surgical approach (DAA or DLA) * Complete a baseline functional assessment using the Activities of Daily Living (ADL) questionnaire before surgery * Have perioperative data collected during hospitalization, including laboratory values, operative details, blood loss, transfusions, analgesic use, complications, length of stay, and in-hospital mortality * Attend follow-up clinic visits at 6 weeks and 3 months after surgery * Complete postoperative functional assessment using the Harris Hip Score at both follow-up visits * Have demographic data, complications, readmissions, and mortality monitored through review of electronic medical records

Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies (HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). The investigators have recently established an improved diagnostic and prognostic index for HM-HLH, termed the Optimized HLH Inflammatory (OHI) index. The OHI index is comprised of the combined elevation of soluble CD25 (sCD25) \> 3,900 U/mL and ferritin \>1,000 ng/mL . However, the true incidence and outcomes of HLH/OHI+ in an unselected cohort are unknown, and so is the mechanism of HM-HLH.

Assessing the efficiency of Prophylactic use of local tranexamic acid during vaginal hysterectomy to reduce blood loss during operation

A randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success.

Serum, synovial fluid and skin biopsies from patients will be collected to the biobank with rheumatoid diseases. These samples will later be used for clinical and basic research, following approval of each specific study by the IRB. The investigators intend to extract protein, DNA and RNA from each sample.

Recently the general medical literature has become aware that the use of certain long-acting insulin analogues could potentially increase cancer risk.During the last few years the investigators group generated information of both scientific and clinical relevance on the proliferative and anti-apoptotic actions of insulin analogues. The goal of this project is to evaluate the hypothesis that the proliferative and signalling activities elicited by insulin analogues may have a impact on tumor behavior. In this study the investigators will asses the biological actions of insulin analogs in primary tumor cells of endometrial and colon cancer.

The objective of this clinical trial is to determine normative Percentage Body-Weight/Weight-Bearing Values and Weight-bearing Gait Characteristics in different physiologic conditions 1. Values in increasing speeds from walking to running. 2. Changing resistance and incline on an elliptical trainer 3. Ground jogging. 4. Stair climbing. 5. Treadmill running. 6. Walking.