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Shock clinical trials

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NCT ID: NCT01668329 Completed - Clinical trials for Immunocompetent Patient on Septic Shock

Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)

BIOSEPSIS
Start date: September 2009
Phase: N/A
Study type: Observational

Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its outcome has not been improved despite the knowledge on inflammatory processes; a reason for these lack of results may lay on the lack of data on the precise dynamics of inflammatory and anti-inflammatory cascades and their consequences. We intend to achieve accurate monitoring of the inflammatory process on a small group of non-immunocompromised patients. Our goal is to obtain quality data, repeated over time, by limiting the technical variability.

NCT ID: NCT01656954 Completed - Shock Clinical Trials

Predicting Volume Response Study

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

The purpose of this study is to understand and document measurements in heart stroke volume (the volume or amount of blood pumped per heart beat) and cardiac output (the volume or amount of blood pumped by your heart per minute) during a passive leg raise maneuver (elevation of the legs), and to determine if these measurements can predict changes in the same as a result of fluid or blood product administration.

NCT ID: NCT01648036 Completed - Septic Shock Clinical Trials

Heparin Anticoagulation to Improve Outcomes in Septic Shock: The HALO Pilot

Start date: July 2012
Phase: Phase 2
Study type: Interventional

Life-threatening infections account for 10% of all intensive care unit admissions and constitute the second more frequent cause of death in the ICU after heart diseases. The most common cause of death in patients admitted with life-threatening infections is multi-organ failure that is mediated by severe inflammation. Given the relationship between inflammation and blood clotting, blood-thinners (also called anticoagulants) have been used to decrease inflammation and the formation of small clots. Several lines of evidence suggest that heparin, a proven and inexpensive blood-thinner, may reduce improve survival in patients diagnosed with life-threatening infection. The primary objective of this study is to demonstrate the feasibility of enrolling patients in a large randomized controlled trial investigating heparin in patients with severe infections. In this study, patients with life-threatening infections will have an equal chance of receiving an intravenous infusion of heparin, or a low dose of a similar drug to prevent of blood clots while patients are immobile. The primary purpose of the study is to demonstrate that an average of 2 patients per site, per month, can be enrolled. Other measures of feasibility include the consent rate, the number of protocol violations that occur during the trial, and the number of dose reductions needed due to excessive anticoagulation. To study the biologic effects of heparin in patients with severe infection, specific laboratory markers will be measured and analyzed. If the feasibility of the trial is confirmed, a large randomized trial designed to tell if heparin can safely improve survival will be conducted. Given its low cost and availability, if heparin is shown to improve survival in patients with severe infection, adoption of this therapy on a global scale is anticipated.

NCT ID: NCT01633502 Completed - Clinical trials for Acute Myocardial Infarction

Danish Cardiogenic Shock Trial

DanShock
Start date: December 2012
Phase: N/A
Study type: Interventional

Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite rapid invasive treatment, circulatory support using positive inotropes and mechanical support with intra-aortic balloon counterpulsation (IABP), and evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%. An alternative to current management is restoration of the volume of blood pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting this is difficult but can be done using the Impella device which is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation thereby restoring blood flow to the failing organs. In 2012 a more powerful Impella has been introduced that is able to deliver 3.5l/min (approximately 75% of a normal cardiac output). The hypothesis of the current study is to reduce mortality and morbidity of patients with cardiogenic shock using the Impella CP. The study will be carried out as a randomized multicenter study where eligible patients will be randomized to receive conventional circulatory support or support with the Impella device and inotropic support if needed. A total of 360 patients are planned to be enrolled, and the primary endpoint will be death.

NCT ID: NCT01632059 Completed - Sepsis Clinical Trials

Examination of ADMA Serum Level and DDAH II

ADSeS
Start date: February 2012
Phase: N/A
Study type: Observational

Examination of ADMA (Asymmetric-Dimethylarginine)-serum level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in patients with severe Sepsis and septic shock as prognostic value. This study looks into ADMA as a good prognostic factor for sepsis. Further more the dependency of the ADMA level to the DDAH II polymorphisms is reviewed this study.

NCT ID: NCT01630577 Completed - Clinical trials for Acute Circulatory Failure

Central Venous Pressure Change With Volume Challenge in Patients With Hemodynamic Instability

CVPCHI
Start date: January 2012
Phase: Phase 3
Study type: Interventional

We conducted this study to assess the value of early change in central venous pressure (CVP) in predicting fluid responsiveness in mechanically ventilated patients.

NCT ID: NCT01618396 Completed - Sepsis Clinical Trials

Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

Start date: March 2011
Phase: N/A
Study type: Interventional

Previous studies have demonstrated that altered microvascular blood flow is an important marker of severe sepsis. Usually, these patients need invasive ventilatory support, frequent use of sedatives and it is unknown if these agents interfere or not on microvascular blood flow. The goal of this study was to compare effects of propofol and midazolam infusions on sublingual microcirculation of septic shock patients.

NCT ID: NCT01612676 Completed - Septic Shock Clinical Trials

Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock

Start date: June 2012
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to investigate the potential of FE 202158 as a treatment which can stabilize blood pressure for treatment of patients in early septic shock.

NCT ID: NCT01611935 Completed - Traumatic Shock Clinical Trials

AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock

AVERTShock
Start date: May 1, 2013
Phase: Phase 2
Study type: Interventional

Trauma patients, who are transfused with multiple blood products to treat shock due to blood loss, frequently develop inappropriately low vasopressin levels. Vasopressin is a hormone necessary to maintain an adequate blood pressure and low levels have been associated with the need for increased transfusions, vasopressors and additional morbidity. Vasopressin is routinely used in the ICU to treat septic shock and other disease processes resulting in decreased vasopressin levels and low blood pressure. This study will investigate the potential benefit of early vasopressin supplementation during the resuscitation of trauma patients and the applicability of using copeptin as a vasopressin biomarker. Trauma patients who receive 6 or more units of blood product within 12 hours of arrival will be randomized to receive a vasopressin bolus plus infusion or a similar volume of a placebo (normal saline) for 48 hours. Serial blood samples will be taken for 5 days post-injury. Clinical and demographic data will be recorded prospectively.

NCT ID: NCT01611753 Completed - Septic Shock Clinical Trials

Red Blood Cell Transfusion Improves Perfusion Parameters in Septic Shock Patients With Hypoperfusion

Start date: April 2004
Phase: N/A
Study type: Interventional

The purpose of this study was to evaluate the immediate effects of red blood cells transfusion on central venous oxygen saturation and lactate levels in septic shock patients randomized to two different hemoglobin levels. The influence of red blood cell (RBC) transfusion on the adequacy of oxygen delivery (DO2) and supply (VO2) could be assessed by systemic oxygen variables such as central venous oxygen saturation (ScvO2) and lactate levels. Although it is not clear that alterations in these parameters actually represent an improvement in the DO2/VO2 ratio, they might represent a better transfusion trigger than the absolute hemoglobin value. Patients admitted with a diagnosis of septic shock and hemoglobin levels lower than 9.0 g/dL , less than 48 hours of shock diagnosis, were included, a central venous catheter in the superior vena cava and signed informed consent. The investigators randomized all patients into two groups. Patients in the liberal group received transfusions immediately, as the objective was to maintain hemoglobin levels above 9.0 g/dL. In the restrictive group, transfusion was withheld until their hemoglobin levels fell below 7.0 g/dL. Each time a patient received a transfusion, the investigators collected a set of laboratory tests, including hemoglobin levels, ScvO2 and lactate, at two time points, immediately before transfusion and one hour after its ending. The sample size was calculated by considering that in 80% of the transfusions in patients in the restrictive group ScvO2 would improve compared to only 45% of those in the liberal group, with an alpha error of 0.05 and 80% power. Improvement was defined as an increase of 5% over the pre-transfusion ScvO2. Twenty-eight transfusions in each group would be necessary, but to correct for potential non-parametric distribution of the main variables, the number was adjusted to 35 transfusions in each group. Trends in ScvO2 and lactate were categorized as worsening or improving. The investigators defined improvement when ScvO2 reached 70% in patients with baseline levels below this threshold or when there was an absolute increase of at least 5% after transfusion. Any increase in patients with previous ScvO2 ≥ 70% was considered to be "no change". Worsening was defined as a reduction of 5% in the previous levels or a decline to less than 70% in patients with pre-transfusion levels in the range of 70 to 75%. The investigators also carried out a ROC curve analysis to assess the accuracy of the pre-transfusion hemoglobin levels, pre-transfusion lactate and pre-transfusion ScvO2 in predicting the patients whose ScvO2 would increase more than 5% with transfusion. For this analysis, the investigators used a different approach because it would also be necessary to analyze patients with a lower chance of response to assess the prediction of response. Thus, this analysis included all patients with ScvO2 below 75%, rather than only those below 70%. As before, the investigators defined improvement as any increase ≥ 5%. The investigators did not consider patients with levels above 75% in this analysis, as the physiological interpretation of this situation is challenging. The investigators considered as altered any lactate levels above 1.5 times the reference level, and a change ≥ 10% was defined as improvement or worsening. In patients with baseline normal levels, the status was recorded as worsening if a 10% increase was detected. Afterwards, the investigators tested the association between these categorized variables and the baseline levels of hemoglobin. The impact on perfusion was also assessed by the determination of Δlactate (lactate post-transfusion x 100/lactate pre-transfusion) and ΔScvO2 (ScvO2 post-transfusion x 100/ScvO2 pre-transfusion), and their correlation with the baseline hemoglobin levels was analyzed using the Spearman correlation test. In all tests, the results were considered significant if the p level was lower than 0.05.