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Hypotension clinical trials

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NCT ID: NCT05569265 Completed - Clinical trials for Postoperative Complications

Hypotension Prediction Index-guided Hemodynamic Optimization Trial to Reduce Postoperative Acute Kidney Injury (HYT).

HYT
Start date: October 8, 2022
Phase: N/A
Study type: Interventional

MAIN AIM OF THE STUDY To establish whether hemodynamic management guided by the hypotension prediction index (HPI) guided by the administration of intravenous fluids and vasoactive drugs in patients undergoing elective major abdominal surgery reduces the incidence of postoperative moderate-severe acute kidney injury (AKI) in the 30 days after surgery. STUDY DESIGN A low intervention level clinical, blinded, controlled, randomized, multicenter, with daily follow-up of patients until hospital discharge and of postoperative complications and mortality 30 days after surgery will be performed. This is a low-intervention clinical trial comparing standard treatments: - The drugs used in the investigation are licensed. - The drugs are used according to the indications contemplated in the technical data sheet and there are published scientific data on their efficacy and safety. - The complementary diagnostic or follow-up procedures entail a very limited additional risk or burden to the safety of the subjects, which is minimal compared to that of standard clinical practice. STUDY DISEASE Intraoperative hemodynamic monitoring and management in surgical patients undergoing major abdominal surgery. STUDY POPULATION AND TOTAL NUMBER OF PATIENTS The sample of this study consists of patients of both genders, aged over 65 years and/or physical status ASA III or IV, undergoing elective major abdominal surgery (abdominal, urological, gynecological) under general/combined anesthesia (using laparoscopic or open approaches. To detect a 5% absolute reduction (from 10% to 5%) in the primary outcome variable (postoperative AKI up to 30 days) with a sample size ratio of 1%, and an overall type I error rate of 5%, we need 870 patients (435 per arm). Assuming a 10% loss rate, the total amounts to 958 patients, 479 for each group. DURATION OF THE STUDY The total planned duration of the overall study, which includes authorization, recruitment of subjects, and follow-up of subjects until completion of the analysis of the results obtained, is 19 months.

NCT ID: NCT05548985 Completed - Hypotension Clinical Trials

Midodrine for Prophylaxis Against Post Spinal Hypotension in Elderly Population

Start date: October 17, 2022
Phase: N/A
Study type: Interventional

Hip fracture is a common and serious healthcare problem which commonly affects elderly populations. The common route of anesthesia for hip arthroplasty is spinal anesthesia. Elderly populations are characterized by high incidence of post spinal anesthesia hypotension; furthermore, elderly patients commonly have systemic medical disorder; therefore, this population is highly vulnerable to perioperative hypotension. Moreover , intraoperative hypotension during hip surgery has been recently recognized as a major risk factor for postoperative morbidity and mortality. Through the effect of spinal anesthesia on sympathetic system Veno-dilatation, decreased venous return, and consequently decreased cardiac output and hypotension will be induced. Vasopressors are commonly used for prophylaxis against post spinal hypotension in different patient subgroups. The commonly used drugs are alpha-adrenoreceptor agonists such as ephedrine, phenylephrine, and recently norepinephrine. All these agents are effective in maintenance of blood pressure; however, they have some disadvantages; ephedrine is commonly associated with tachycardia, phenylephrine and norepinephrine are associated with bradycardia. All the former mentioned drugs are used intravenously. Midodrine hydrochloride is another alpha-adrenoreceptor agonist drug which is used for management of various hypotensive disorders. Midodrine is the prodrug which is metabolized to desglymidodrine which is a direct arteriolar and venous vasopressor. Midodrine is characterized by being an oral drug, with minimal central nervous system side effects, and good oral bioavailability. No studies had evaluated the efficacy of midodrine for prophylaxis against post-spinal anesthesia hypotension in elderly population. Aim of the work: This thesis aims to evaluate the efficacy and safety of oral 5 mg of midodrine compared to placebo in prophylaxis against post-spinal hypotension in elderly patients undergoing hip arthroplasty

NCT ID: NCT05548920 Completed - Clinical trials for Total Fluid Volume Decreased

Preoperative Ultrasound Guided Evaluation of SVC-CI and IVC -CI as Predictors of Hypotension After Induction of Anaesthesia in Major Onco-surgery

SVC IVC CI
Start date: June 26, 2021
Phase:
Study type: Observational

Patients undergoing major Oncosurgeries are fluid deficit due to preoperative fasting , inadequate intake due to disease hence prone to development of hypotension after induction of general anaesthesia owing to vasodilatory effects of anesthetic induction agents. Investigators plan study to measure ultrasound guided Superior Vena Cava and Inferior Vena Cava collapsibility Index as predictors of hypotension after induction of General anaesthesia.

NCT ID: NCT05540457 Completed - Clinical trials for End Stage Renal Disease

Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)

Start date: September 22, 2022
Phase: N/A
Study type: Interventional

Prospective, single center, open label, non-randomized, post-market study of the Tablo Hemodialysis System and VitalStream Monitor in participants with End-Stage KidneyDisease undergoing In-Center Hemodialysis.

NCT ID: NCT05529147 Completed - Hypertension Clinical Trials

The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly

BLUEBERRY
Start date: September 5, 2022
Phase:
Study type: Observational

Rationale: Systolic hypertension represents the leading risk for burden of disease among older adults (age >70 years), with an increasing prevalence due to the increase in lifespan. Antihypertensive drug treatment (AHT) is beneficial in fit (non-frail) older adults, with substantial (≈40 %) risk reductions for cardiovascular events and mortality. Scarce evidence exists on the risks of adverse effects related to AHT. It has been suggested in medical literature that AHT in frail elderly might cause cerebral hypoperfusion and/or orthostatic hypotension. Therefore, current guidelines advise clinicians to be more cautious regarding treatment targets in this population. However, the evidence for these adverse effects is limited to observational and cross-sectional data and opinion pieces. In contrast to the suggestion of potential adverse effects of AHT in elderly, recent experimental data and secondary analyses of clinical trials do not provide support for this statement. However, evidence in frail older patients remains scarce. Studies that directly examine the safety of AHT with regard to cerebral hemodynamics and orthostatic tolerance in frail elderly are needed to inform potential changes in current treatment guidelines and prevent undertreatment of hypertension in frail older patients. Objective: To examine the impact of medication induced systolic BP (SBP) reductions ≥10 mmHg, while reaching a treatment target of ≤140 mmHg, on cerebral blood flow (CBF) in frail elderly with untreated or uncontrolled systolic hypertension at baseline. We hypothesise that these blood pressure lowering targets (which are consistent with clinical guidelines for non-frail older patients) are not accompanied by detrimental reductions in CBF (i.e. >10% from baseline). Study design: An explorative observational study will be performed to examine the effects of medication induced SBP reductions ≥10 mmHg to office SBP ≤140 mmHg on CBF in frail elderly with untreated or uncontrolled hypertension. Participants will be treated as in usual patient care for older adults with hypertension. Participants will undergo one baseline assessment before exposure to (additional) AHT, followed by in duplo follow-up assessments 6-10 weeks after the start of AHT. The in duplo follow-up evaluations will be performed on separate days within 2 weeks while continuing treatment. Study population: Twelve frail (Clinical Frailty Scale 4-7) elderly (age ≥70 years) with untreated or uncontrolled systolic hypertension (office SBP ≥150 mmHg) that will be subjected to (additional) AHT as part of regular care. Main study parameters/endpoints: The change in resting CBF from baseline to follow-up (i.e. the average of the in duplo follow-up assessments). Secondary outcomes relate to cerebrovascular autoregulation (CA) and orthostatic tolerance. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will be subjected to AHT, essentially identical to what is considered 'guideline care', while their wellbeing will be monitored closely. Since all study procedures and used measurement techniques are non-invasive, the nature and extent of burden and risks associated with participation and measurements are negligible.

NCT ID: NCT05526625 Completed - Clinical trials for Ultrasound Based IVC IJV

Comparison Of Ultrasound-Based Measures Of Inferior Vena Cava And Internal Jugular Vein For Prediction Of Hypotension During Induction Of General Anesthesia

Start date: June 1, 2020
Phase:
Study type: Observational

Hypotension after induction of general anesthesia is a frequent event in routine practice. Even a short period of hypotension may lead to tissue hypoperfusion and predispose to postoperative complications. Intra-operative hypotension is associated with renal injury, ischemic stroke, myocardial injury and postoperative mortality in patients having non-cardiac surgery under general anesthesia. Underlying hypovolemia is an important and modifiable risk factor for hypotension after anesthetics administration. Ultrasonographic studies of the inferior vena cava (IVC) and the internal jugular vein (IJV) for evaluation of intravascular volume status and prediction of hypotension during induction of general anesthesia have been established. The present study was designed to compare, on ultrasound-based measures, between inferior vena cava and internal jugular vein for prediction of prolonged hypotension during induction of general anesthesia. The study was conducted at Kasr Al-Ainy hospital, Cairo University in Patients undergoing elective non-cardiac surgery under general anesthesia.

NCT ID: NCT05522088 Completed - Clinical trials for Comparing Ephedrine With Norepinephrine for Mangement Postspinal Hypotension

Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Post Spinal Hypotension

Start date: March 1, 2022
Phase:
Study type: Observational

This study was conducted to compare the effectiveness of ephedrine versus norepinephrine for management of hypotension after spinal anesthesia for mothers undergoing elective cesarean section

NCT ID: NCT05509764 Completed - Hypotension Clinical Trials

The Effect of Oxygen Therapy on Atelectasis

Start date: May 1, 2021
Phase:
Study type: Observational [Patient Registry]

In pregnancy, cephalal shift of the diaphragm caused by the enlarged uterus reduces the functional residual capacity and may increase the closure volume and predispose the pregnant woman to airway closure, leading to atelectasis. The development of atelectasis due to dermatomes retained in spinal anesthesia and intraoperative supine position may increase further. Oxygen therapy to be applied may also lead to absorption atelectasis by causing hyperoxia. The aim of our study is to evaluate the effect of oxygen support on the lungs in cesarean section operations under spinal anesthesia by lung ultrasound score and oxygen reserve index.

NCT ID: NCT05504629 Completed - Metabolic Syndrome Clinical Trials

Interindividual Postexercise Hypotension Response in Morbid Obesity

Start date: March 5, 2019
Phase: N/A
Study type: Interventional

A quasi-experimental study developed in sedentary morbidly obese men and women (age 43.6±11.3 y; body mass index [BMI] ≥40 kg/m2) were assigned to a CT group of ET plus RT (ET+RT; n=19; BMI 47.8±16.7) or RT plus ET order group (RT+ET; n=17; BMI 43.0±8.0). Subjects of both groups received eight exercise sessions over four weeks. Systolic (SBP), diastolic (DBP), mean arterial pressure [MAP], heart rate at rest [HR], and pulse pressure [PP] measurements before and after 10 minutes postexercise. Secondary outcomes were other anthropometric, body composition, metabolic, and physical condition parameters. Using the ∆SBP reduction, and quartile categorization (Q) in 'high' (Rs: quartile 4), 'moderate' (MRs: quartile 3), 'low' (LRs: quartile 2), and 'nonresponders' (NRs: quartile 1) were reported.

NCT ID: NCT05502146 Completed - Clinical trials for Cesarean Section Complications

Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Maternal Hypotension

Start date: August 17, 2022
Phase: Phase 4
Study type: Interventional

In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 8 mcg) in management of maternal hypotensive episode after spinal block during cesarean delivery.