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35 active trials for Hypotension

The Hemodynamic Effects of Vasopressin in Patients With Fontan Physiology

The goal of this study is to evaluate if vasopressin can elevate systemic arterial blood pressures without having a significant effect on pulmonary arterial pressures. Because patients who have undergone Fontan procedures rely on low pressures across the pulmonary vascular bed to maintain cardiac output, vasoactive agents that concomitantly increase systemic and pulmonary pressures may have a deleterious effect in this specific patient population. Hypothesis: In patients with Fontan physiology, vasopressin will increase systemic BP by 20% above baseline, without increasing the transpulmonary gradient.

Start: August 2020

Dapagliflozin on Hypotensive Heart Failure Patients After Sacubitril/Valsartan Therapy

The DAPA-HF trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure events and cardiovascular death comparing to placebo in patients with reduced ejection fraction further to standard of care. However, hypotensive patients who generally have higher risks comparing to normotensive patients, were under represented in the DAPA-HF. The investigators aimed to evaluate clinical effects of dapagliflozin on hypotensive heart failure patients receiving chronic sacubitril/valsartan treatment.

Start: May 2020

Diastolic Performance and Norepinephrine in Spinal-Induced Hypotension for Cesarean Delivery

Background and rationale: The best agent to prevent spinal-induced hypotension is still uncertain but norepinephrine showed fewer effects on heart rate and cardiac output. In septic patients norepinephrine has been shown to produce an "endogenous fluid challenge". Objective: We aim to assess if patients with impaired diastolic function (46% of pregnant women at term) are less able to maintain indexed cardiac output in response to norepinephrine infusion during spinal-induced vasoplegia. We also aim to assess if fetal wellbeing is related to maternal cardiac output during spinal anesthesia for cesarean delivery. Methods: We will assess by echocardiogram the diastolic function before surgery and will then start continuous non-invasive hemodynamic monitoring with a ClearSight® monitor (ClearSight®, Edwards Lifescience, Irvine, CA) and perform a fluid challenge to relate diastolic disfunction with fluid responsiveness. Hemodynamic monitoring will continue throughout the surgery. Norepinephrine infusion will start concomitantly to beginning of spinal anesthesia and will stop 5 minutes after uterotonic medication. Outcome: We aim to assess if patients with diastolic disfunction are less able to maintain cardiac output in response to norepinephrine infusion during spinal anesthesia induced vasoplegia. We also aim to assess if fetal wellbeing is related to maternal cardiac output during spinal anesthesia for cesarean delivery.)

Start: January 2020

Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV

The primary objective of this study is to evaluate the dose effect of Phenylephrine Hydrochloride Injection on the treatment of clinically relevant decreased blood pressure in the pediatric population, ≥12 to 16 year old patients undergoing general and neuraxial anesthesia. The secondary objectives are to describe changes in blood pressure and heart rate, time to onset and to maximal response, and the duration of response; to assess the safety of the product in this population; and to characterize the pharmacokinetics of phenylephrine hydrochloride.

Start: February 2015

RAAS and Arterial Stiffness in SCI

The study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls.

Start: June 2018

Hypotension Prediction Index Study (HPI Study)

A prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the Acumen HPI Software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP)

Start: May 2019

Treatment of Post-SCI Hypotension

While treatment strategies for OH have been identified for use in persons with acute SCI, the field of SCI medicine lacks a gold standard for treatment thresholds and well-defined outcome parameters. Comprehensively documenting the impact of orthostatic hypotension (OH), regardless of symptoms, during acute rehabilitation and identifying the effects of two different treatment approaches on therapy participation and adherence to an intended rehabilitation plan could have a significant impact on clinical practice in the acute rehabilitation setting following SCI.

Start: June 2017

Norepinephrine for Hypotension in Cesarean Section

Hypotension is a very common consequence of the sympathetic vasomotor block caused by spinal anesthesia for cesarean section. Maternal symptoms such as nausea, vomiting and dyspnea frequently accompany severe hypotension, and adverse effects on the fetus, including depressed APGAR scores and umbilical acidosis, have been correlated with severity and duration of hypotension. Because hypotension is frequent, vasopressors should be used routinely and preferably prophylactically.

Start: April 2020

Hypotension During Extracorporeal Circulatory Support Indicated for Cardiogenic Shock

The cardiogenic shock is characterized by an alteration of organs function following a decrease in cardiac output linked to an impairment of cardiac performance. The prognosis remains poor with mortality between 40 and 50%. Nowadays, Extracorporeal Life Support (ECLS or VA-ECMO) is the referent therapy to restore blood flow in the body when medical treatment is not sufficient. Despite a good blood flow provided by the ECLS, many patients develop a severe hypotension (so called vasoplegia) due to a loss of vascular resistance mainly explained by the inflammatory response to shock and extracorporeal circulation. The treatment of this reaction includes vasopressors (Norepinephrine in usual care) and serum surrogate perfusion to achieve a mean arterial pressure (MAP) above 65 mmHg. The purpose of this study is to describe the patients with vasoplegia among a retrospective cohort of patients treated with an ECLS in our university center, over the 4 last years, to determine major complication rate (including death, kidney failure and arrythmias) and their outcome. This study will provide consistent data useful for further trials about targets of pressure and treatments to increase blood pressure during ECLS.

Start: June 2019

Dynamic Parameters in Evaluation of Fluid Responsiveness

Intravenous infusion of fluids in patients after surgery is a very important part of treatment. However, administering too much or too little fluid can lengthen the stay in the intensive care unit or even harm the patient. Therefore, fluid therapy should be tailored to the individual needs of each patient. Several methods are available to assess which patients will likely benefit from fluid administration. However, each of these methods is useful only under certain conditions. The study aims to explore some less-known, yet promising tests which could make adequate fluid administration more precise and easier to achieve.

Start: February 2020

Dose Response to the Norepinephrine Precursor Droxidopa in Hypotensive Individuals With Spinal Cord Injury

The goal of this study is to determine the efficacy of the drug Droxidopa (Northera) in increasing blood pressure in subject with hypotension, low blood pressure, which is classified as blood pressure less than 110/70 in males and 100/70 in females. The first aim is to determine the proportion of subject with Spinal Cord Injury (SCI) who have a normotensive response to Droxidopa. The second is to determine the proportion of subject with SCI who express a hypertensive response to Droxidopa. A Normal blood pressure ranges from 111-139 in males and 101-139 in females and a hypertensive blood pressure is anything higher than 140 in males and females. The study would take place in James J. Peters VA Medical Center (JJPVAMC) and The Icahn School of Medicine at Mount Sinai (ISMMS) in Manhattan, New York.

Start: June 2018

Influence of the "Hypotension Probability Index" on Intraoperative and Postoperative Hypotension in ENT- and OM-Surgery

The aim of the project is to investigate whether the use of the HPI can reduce the number and duration of intra- and postoperative hypotension in ventilated patients during and two hours after extensive surgery in the head and neck area compared to the established monitoring.

Start: October 2019

The "Hypotension Prediction Index" in Patients Undergoing Lung Surgery

The "Hypotension Prediction Index (HPI)" was established by the Edwards Lifescience Company (Irvine, California, USA) and is CE certified. As part of the Edwards Acumen Decision-Support-Software-Suite the HPI is supported by the minimal invasive FloTrac Sensor. The HPI displays the probability of an occurring hypotension. The software was established with the help of 20.000 analyzed patient events. If the upper limit of the HPI is reached, the software is alarming the treating physician 8. At the university hospital of Giessen HPI analyses are used in the daily clinical routine as well as for scientific purposes. Preliminary data of the HPI-I-Trial ("Influence of the Hypotension Prediction Index on the number and duration of intraoperative hypotension in primary hip-endoprothetic replacement", University Hospital of Giessen) included patients, which underwent hip-endoprothetic replacement surgery and revealed that the use of HPI with a goal directed therapy (GDT) protocol compared to standard care significantly reduced the incidence and duration of intraoperative hypotension. Therefore HPI with GDT might reduce the incidence of hypotension related complications in a sicker patient cohort. The aim of the study is to investigate whether a goal directed treatment according to the Hypotension Prediction Index compared to standard care can reduce the incidence of intraoperative hypotension in patients under single lung ventilation.

Start: November 2019

Norepinephrine and Phenylephrine, Which Better for Elderly?

this is a prospective, double-blinded and single-center study. this study is based on the Stroke volume variation fluid guided therapy, to compare the effects of norepinephrine and phenylephrine in treating perioperative hypotension, and to find the safest and most effective vasopressor for elderly.

Start: October 2019

Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia

Hypotension is frequently encountered after induction of general anesthesia. It can be pronounced in elderly patients and can require administration of vasopressor agents including ephedrine and phenylephrine. Intraoperative hypotension, especially prolonged episodes, can contribute to an increase in morbidity and mortality in the postoperative period as suggested by some former studies. The investigators hypothesize that fentanyl can contribute to the decrease in blood pressure (BP) that is seen after induction of general anesthesia in older patients. This hypotension may be due to fentanyl blocking effect on the sympathetic nervous system. This study will be the first one to examine the effect of fentanyl administration on blood pressure in elderly patients with induction of general anesthesia prior to the start of surgery. If the study shows that fentanyl contributes to hypotension during this period, it may lead to a change in practice and better patient outcomes and mortality rates.

Start: February 2018