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Hypovolemic Shock clinical trials

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NCT ID: NCT04056065 Completed - Blood Loss Clinical Trials

PMZ-2010 (Centhaquine) as a Resuscitative Agent for Hypovolemic Shock

Start date: May 29, 2017
Phase: Phase 2
Study type: Interventional

This is a prospective, multi-centric, randomized, double-blind, parallel, controlled phase-II efficacy clinical study of PMZ-2010 therapy in patients with hypovolemic shock. Centhaquine is highly safe and well tolerated. Toxicological studies showed high safety margin in preclinical studies. Its safety and tolerability has been demonstrated in a human phase I study in 25 subjects (CTRI/2014/06/004647; NCT02408731).

NCT ID: NCT04045327 Completed - Hypovolemic Shock Clinical Trials

Efficacy of PMZ-2010 (Centhaquine) a Resuscitative Agent for Hypovolemic Shock

Start date: January 31, 2019
Phase: Phase 3
Study type: Interventional

This is a prospective, multi-centric, randomized, double-blind, parallel, controlled phase-III efficacy clinical study of PMZ-2010 therapy in patients with hypovolemic shock. Centhaquine (previously used names, centhaquin and PMZ-2010; International Non-proprietary Name (INN) recently approved by WHO is centhaquine) has been found to be an effective resuscitative agent in rat, rabbit and swine models of hemorrhagic shock, it decreased blood lactate, increased mean arterial pressure, cardiac output, and decreased mortality. An increase in cardiac output during resuscitation is mainly attributed to an increase in stroke volume. Centhaquine acts on the venous α2B-adrenergic receptors and enhances venous return to the heart, in addition, it produces arterial dilatation by acting on central α2A-adrenergic receptors to reduce sympathetic activity and systemic vascular resistance.

NCT ID: NCT02924792 Completed - Hemorrhagic Shock Clinical Trials

Sternal Intraosseous Transfusion of Autologous Whole Blood: A Comparison of Flow Rates and Degree of Hemolysis

Start date: November 2016
Phase: N/A
Study type: Observational

In this study the impact of two CE marked and FDA approved sternal needles in comparison to intravenous access on the flow-rate of autologous reinfusion of whole blood and the possible hemolysis of red cells post-transfusion in a population of healthy military officers is investigated.

NCT ID: NCT02772653 Completed - Trauma Clinical Trials

Evaluation of Resuscitation Markers in Trauma Patients

Start date: May 2016
Phase:
Study type: Observational

Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. Consequently, it is important to define better resuscitation markers for these patients. This investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). There will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. Each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. The objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.

NCT ID: NCT02675725 Completed - Surgery Clinical Trials

Kinetics of the Sublingual Microcirculation During Fluid Bolus

Start date: November 2015
Phase:
Study type: Observational

Fluid therapy is one of the cornerstones of the treatment of organ failure. The investigators assume that fluid bolus will increase the delivery of oxygen to the cells and resolve the shock. The purpose of this study is to asses kinetics of the sublingual microcirculation in one place during a fluid bolus. It is expected that fluid therapy after normalization of the red blood cell flow velocity in the microcirculation will result in a decrease in capillary density through the formation of edema in the tissues. This can be considered to be the tipping of potentially beneficial to deleterious effects of fluid therapy. After cardiac surgery patient will be transferred to the ICU for further stabilisation. Within specific indications the patient will receive a fluid bolus, these indications are hypotension, hyperlactataemia, tachycardia or decreased urine production. The fluid bolus will be 250 ml crystalloids in 15 minutes. The investigators will observe the sublingual microcirculation during this fluid bolus. To asses the red blood cell velocity and capillary vessel density on one spot during this fluid bolus.

NCT ID: NCT02584803 Completed - Hypotension Clinical Trials

Inferior Vena Cava Assessment in Term Pregnancy Using Ultrasound: a Feasibility Study of Subxiphoid and RUQ Views

Start date: May 2016
Phase:
Study type: Observational

This study is to assess the feasibility of 2 different ultrasound views of the inferior vena cava (IVC), a large vein that returns blood to the heart. Ultrasound is safe in pregnancy and, is regularly used to evaluate the fetus. It is hoped that imaging of the IVC will then allow us to determine the fluid status of the parturient which could be helpful in treating hemodynamic instability. This study will not involve any change in management of the participating patients.

NCT ID: NCT02558166 Completed - Septic Shock Clinical Trials

Renal Resistive Index in Patients With Shock

Start date: August 2015
Phase: N/A
Study type: Observational

This study consists of two substudies. The first substudy: 'Renal resistive index in critically ill patients with cardiogenic and septic shock' Design: cross-sectional observational Aim of this project is: 1. to determine whether critically ill patients with cardiogenic and septic shock have an elevated Renal Resistive Index and 2. to determine whether Renal Resistive Index differs between cardiogenic/hypovolemic shock and shock due to sepsis/systemic inflammation (SIRS) 3. to determine the relation between the (change in) renal vascular resistance and - Markers of the systemic - and the microcirculation - Fluid status as quantified by bioimpedance analysis - Concomitant renal function The second substudy: 'Predictive value of the Renal Resistive Index on ICU admission and its course for the development of acute kidney injury in critically ill patients with cardiogenic and septic shock' Design: longitudinal observational The aim of this project is: 1. to determine whether the renal resistance index on admission to the intensive care unit can predict the development of acute kidney injury (AKI) in critically ill patients with shock 2. to investigate if the renal resistance index on admission to the intensive care unit is an independent predictor of the development of AKI or depends on the severity and duration of shock and other known risk factors of AKI such as comorbidity and use of nephrotoxic drugs Aim of the large research project is to determine whether the Renal Resistive Index could become a monitoring tool for intervention studies aiming to prevent acute kidney injury or protect the kidney.

NCT ID: NCT00488462 Completed - Hemorrhage Clinical Trials

Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe

NASG
Start date: October 2007
Phase: N/A
Study type: Interventional

This trial will address the question of whether early application of the Non-pneumatic Anti-Shock Garment (NASG) at the Satellite Health Facility (SHF) level before transport to a Referral Hospital (RH) will decrease maternal mortality and morbidity. The available evidence indicates that the NASG substantially decreases blood loss, but there is no evidence that its application will reduce extreme adverse outcomes. It is also not known if possible side effects associated with NASG use might outweigh potential benefits. This study would rigorously test the effectiveness of the NASG using an experimental design with adequate power to detect statistically significant decreases in morbidity and mortality.

NCT ID: NCT00305253 Completed - Hemorrhage Clinical Trials

Efficacy Study of the Non-Pneumatic Anti-Shock Garment (NASG) in Egypt

Start date: April 2006
Phase: Phase 1/Phase 2
Study type: Interventional

This study will test the efficacy of the NASG on women suffering from obstetric hemorrhage as compared to hemorrhaging women who do not receive the NASG.