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Hypotension clinical trials

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NCT ID: NCT01434251 Recruiting - Hypotension Clinical Trials

Treatment of Hypotension of Prematurity (TOHOP)

TOHOP
Start date: September 2011
Phase: N/A
Study type: Interventional

Hypotension in the very preterm infant (gestational age [GA] <32 wks) is a frequently occurring clinical problem. Although no real consensus has been reached on the definition of hypotension in these infants, in clinical practice a mean blood pressure (mean BP) in mmHg lower than the GA age in weeks is considered to be the starting point for anti-hypotensive therapy. However, although an association between neonatal hypotension and mortality/ morbidity exists, there is no evidence of causality between hypotension (meanBP <GA in completed weeks) and neonatal mortality/morbidity. In addition, using mean BP alone as the indication of treatment of neonatal cardiovascular compromise without taking into consideration the status of tissue perfusion may lead to unnecessary exposure of neonates to vasoactive medication. This medication can be potentially harmful to these extremely vulnerable patients. The aim of this study is to compare neonatal mortality and short-term neurodevelopmental outcome (cerebral ultrasound during the first 7 days of life, advanced MRI indices of structural brain injury at term GA) and long-term neurodevelopmental outcomes (Bayley scales of infant development III [BSID-III] at 24 months) between two groups of very preterm infants presenting with hypotension without clinical and laboratory evidence of compromised tissue perfusion during the first 3 days of life. Hypotension will be defined as the mean BP (in mm Hg) lower than the infant's GA (in weeks). Patients randomized to "Group A" will be treated according to the treatment protocol operative in the Neonatal Intensive Care Unit (NICU) of the University Medical Centre Utrecht (UMCU) while "Group B" will receive no cardiovascular support for hypotension unless they have evidence of compromised tissue perfusion and end-organ function ((i.e. near infrared-monitored regional cerebral oxygen saturation (ScO2) <50% despite optimized ventilatory support and FiO2 administration, plasma lactate >6 mmol/L; and/or urine output <0.6 mL/kg/hour) or mean BP >5mmHg lower than the current guideline. The investigators hypothesize that there will be no differences between the two groups concerning short and long-term neurodevelopmental outcomes.

NCT ID: NCT01434121 Completed - Sepsis Clinical Trials

Ascorbic Acid (Vitamin C) Infusion in Human Sepsis

Start date: May 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The major goal of this project is to determine whether intravenously infused ascorbic acid is safe for use as a viable therapeutic strategy in adult humans with sepsis.

NCT ID: NCT01427686 Active, not recruiting - Clinical trials for Arterial Hypotension

Dopamine Versus Dobutamine for Treatment of Arterial Hypotension in Term and Preterm Neonates

Start date: June 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine the effects of Dobutamine as compared to Dopamine in term and preterm neonates with arterial hypotension on cerebral and renal oxygenation, fractional tissue oxygen extraction, mean arterial blood pressure and cardiac output. The investigators hypothesize that Dopamine has a stronger effect on blood pressure than Dobutamine but Dobutamine has a stronger effect on cerebral oxygenation and cardiac output than Dopamine.

NCT ID: NCT01419106 Completed - Hypotension Clinical Trials

Sonography in Hypotension and Cardiac Arrest in the Emergency Department.

SHoC-ED
Start date: August 2011
Phase: N/A
Study type: Interventional

This study is designed to determine if there is any relationship between performing an abdominal ultrasound on patients who present with hypotension and their clinical outcomes (as measured by 7, 30 day and discharge mortality).

NCT ID: NCT01418118 Completed - Clinical trials for Head and Neck Cancer

Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery

Free4Flow
Start date: October 2008
Phase: Phase 4
Study type: Interventional

Following surgery to remove tumours of the head and neck, patients undergo reconstruction with free flaps - tissue that is taken from elsewhere in the body and given a new blood supply by attaching it to vessels in the neck. Following this type of surgery, patients often need medication to maintain their blood pressure in the intensive care unit. The effect of these drugs on the transplanted tissues is unknown. This study investigates the effects of four commonly used drugs on free flap perfusion.

NCT ID: NCT01415284 Recruiting - Hypotension Clinical Trials

ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia

Start date: October 2011
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal anesthesia.

NCT ID: NCT01414842 Completed - Hypotension Clinical Trials

HFR A-equilibrium on Cardiovascular Stability

AIMS
Start date: April 2007
Phase: Phase 4
Study type: Interventional

Aim of the present randomized controlled multinational trial is the comparison of a novel biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy, with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic overall and cardiovascular stability.

NCT ID: NCT01414777 Completed - Pregnancy Clinical Trials

Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients

Start date: November 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators hypothesize that given prophylactically, intravenous ondansetron will attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia. Eighty-six American Society of Anesthesiologists (ASA) physical status I or II in preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo elective caesarean section will be enrolled. Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy will randomize and dispense study drug. Baseline measurements of vital signs will be taken. Otherwise standard management will then be used: - Patients must be NPO for 8 hours - Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3 minutes, more frequently if decided by the provider. - Standard lumbar puncture in a sitting position the L3-L4 or L4-L5 - Whitacre pencil-point, 25 gauge - Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20 mcg fentanyl - Immediately after completing the subarachnoid injection, patients will be laid supine with left lateral uterine displacement The sensory level of anesthesia will be assessed in the standard fashion every five minutes using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0, no paralysis; 1, inability to lift the thigh [only knee/feet]; 2, inability to flex the knee [only feet]; 3, inability to move any joint in the legs).

NCT ID: NCT01400126 Not yet recruiting - Clinical trials for System as Compared to Conventional Water System.

Ultrapure Water System for Hemodialysis Therapy

Start date: August 2011
Phase: N/A
Study type: Observational

We wish to compare the effect of very clean water used for dialysis therapy (i.e ultrapure water) in comparison with the use of conventional water which are used in most dialysis units worldwide. To the best of our knowledge prospective data in that field is sparse.

NCT ID: NCT01393782 Completed - Septic Shock Clinical Trials

Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study

ATHOS
Start date: July 2011
Phase: Phase 1
Study type: Interventional

The investigators propose a dose finding study to determine the feasibility of Angiotensin II (AII) to increase mean arterial pressure in high-output shock. If AII can be shown to increase mean arterial pressure, this could lead to future pharmacologic development based on the AII hormonal pathway. The investigators propose a 20 patient, randomized, placebo-controlled, blinded study in the treatment of high-output shock. Patients with high-output shock and a cardiovascular SOFA (sequential organ failure score) score of > 4 will be eligible. In addition, patients must already be receiving cardiac output monitoring and have a cardiac index > 2.4 L/min/ 1.73 m2. Patients will be randomized to intravenous AII or saline in a blinded fashion. There will be 10 patients in each arm. This is a safety and dose finding feasibility study. The investigators are starting with a small cohort consistent with similar types of studies. The investigators estimate that ten patients in each arm will generate a basis for determining if there is sufficient signal for AII to improve blood pressure at the doses outlined. The primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a mean arterial pressure (MAP) of 65 mmHg. Secondary endpoints will be the effect of AII on urine output, serum lactate, and creatinine clearance. 30 day post dose mortality will also be assessed. Subjects discharged prior to day 30 will be contacted by telephone for this assessment.