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NCT ID: NCT03374449 Completed - Surgery Clinical Trials

Impact of Renin-Angiotensin System Inhibitors Continuation on Outcome After Major Surgery

STOPORNOT
Start date: February 6, 2018
Phase: N/A
Study type: Interventional

More than 200 million major surgical procedures are performed annually worldwide. Many of these patients have comorbidities including hypertension and/or heart failure. Chronic treatment of hypertension and/or heart failure very often includes a Renin-Angiotensin System (RAS) inhibitor (Angiotensin-Converting Enzyme Inhibitors (ACE-Is) or Angiotensin Receptor Blockers (ARBs). To stop or not to stop these medications before major surgery remain unknown. Data on management of RAS inhibitors before major surgery and anesthesia remain lacking and matter of debate. It is much likely that the strategy regarding management of RAS inhibitors in the peri-operative setting have important impact on peri-operative complications. The lack of evidence leads to conflicting guidelines with respect to RAS inhibitors management before major surgery. While French guidelines are to stop RAS inhibitors patients with hypertension to avoid profound anesthestic-drugs-induced hypotension, international guidelines differ. The American heart association task force states that continuation of RAS inhibitors perioperatively is reasonable (class IIa recommendation,level of evidence: B). The purpose of this study is to determine the prognostic impact of withholding vs continuing ARBs before major non cardiac surgery.

NCT ID: NCT03374371 Completed - Clinical trials for Staphylococcus Epidermidis Positive Blood Culture

Invasive Markers of Staphylococcus Epidermidis

SepiNGS
Start date: March 1, 2018
Phase:
Study type: Observational

The purpose of the study is to identify biomarkers allowing the distinction between invasive and non-invasive strains of Staphylococcus epidermidis. This distinction is important to determine if the patient is infected and, as a consequence, if an antibiotic treatment is required.

NCT ID: NCT03373864 Completed - Hip Fractures Clinical Trials

Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia for the Hip Fracture Surgery

RACHYP
Start date: January 11, 2018
Phase: N/A
Study type: Interventional

Hip fracture is a frequent pathology, involving elderly patients with many co-morbidities ; therefore, post-operative morbidity and mortality is high. It is reported that intra-operative hemodynamics correlate with post-operative complications such as myocardial injury after non-cardiac surgery (MINS) or acute kidney injury (AKI) ; that is why elderly patients undergoing hip fracture surgery should benefit from a better hemodynamic stability. Low-dose hypobaric lateral spinal anesthesia with a reduced dose of local anesthetic has been shown to have better hemodynamic stability than conventional spinal anesthesia. It has also been reported that general anesthesia and conventional spinal anesthesia in elderly patients undergoing hip fracture surgery have the same hemodynamic effect. However, no published study has compared low-dose hypobaric lateral spinal anesthesia to general anesthesia with regards to hemodynamic effects. The aim of the present study is to compare the intra-operative hemodynamics of low-dose hypobaric lateral spinal anesthesia with that of general anesthesia in elderly patients undergoing hip fracture surgery.

NCT ID: NCT03373851 Completed - Surgery Clinical Trials

Sublingual Sufentanil PCA Usability for Postoperative Pain (Zalviso® System)

USE-SSPC
Start date: June 25, 2018
Phase:
Study type: Observational

Intravenous patient-controlled analgesia (iv-PCA) is the gold standard for the treatment of moderate to severe postoperative pain. It is used in more than 20% of cases after major surgery. Well known disadvantages of this method include the need of intravenous line (invasive, infection risk), the risk of pump programming error, possible delay for ambulation/barrier for enhanced rehabilitation programmes, and time/resource demanding (the need of preparation and installation). Sublingual sufentanil based PCA (Zalviso®) addresses cited issues. The safety and analgesia efficiency of this system is well described. However, the usability and satisfaction of Zalviso® varies depending on clinical settings. The goal of this study is to evaluate the usability and satisfaction of patients, nurses, and physical therapists using Zalviso® System during the first 72 hours in the settings of Enhanced Recovery After Surgery protocol after major interventions associated with moderate to severe postoperative pain.

NCT ID: NCT03373838 Completed - Aging Clinical Trials

Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient

OPTAH
Start date: January 5, 2018
Phase:
Study type: Observational

The main object is to identify and understand why some hospitalized aged patients oppose himself to treatment or diagnosis procedure. This mixed study will used a census in a geriatrics department and a qualitative research.

NCT ID: NCT03373630 Completed - Clinical trials for Intravascular Device

Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter

TIM-GHM
Start date: January 16, 2018
Phase: N/A
Study type: Interventional

The Midline catheter is a peripherally-inserted catheter, with the distal tip being placed at or below the level of the axilla. It is a relevant alternative to other catheters in case of limited venous access and long-run perfusions. Moreover, another significant advantage may be the reduction of the risk of infection. However, the Midline catheter is poorly described in scientific literature, essentially through retrospective and meta analyses including multiple types of catheters (Piccline, CVC, PAC). Therefore, the TIM-GHM study aims to prospectively assess the rate of infections in case of the Midline catheter. The results of this study could bring a collective benefit in terms of knowledge and reliability of these intravascular devices. Depending on these results, a randomized, controlled study will be considered, in order to compare the Midline catheter to its main alternative : the Piccline.

NCT ID: NCT03373461 Completed - IgA Nephropathy Clinical Trials

Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation

Start date: February 7, 2018
Phase: Phase 2
Study type: Interventional

Efficacy and safety of LNP023 in IgAN patients

NCT ID: NCT03373383 Completed - Clinical trials for Drug-resistant Epilepsy

Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy

ARISE
Start date: February 12, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study is to characterize the dose-response relationship with respect to efficacy of Padsevonil administered concomitantly with up to 3 anti-epileptic drugs (AEDs) for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.

NCT ID: NCT03373370 Completed - Diagnosis Clinical Trials

Early Diagnosis of TTR Amyloidosis by Use of Molecular Biology

ADDITION
Start date: March 17, 2017
Phase:
Study type: Observational

Peripheral neuropathies are diseases that affect the nervous system outside the brain and spinal cord, their prevalence is 1% in the general population, the causes are extremely varied with more than 200 identified causes; the main ones are diabetes, excessive alcohol consumption and chemotherapy. They may be sometimes disabling but generally preserve autonomy. Transthyretin amyloidosis is a rare multisystematic hereditary disease with autosomal dominant transmission. They present usually as a peripheral neuropathies (FAP). They are due to a point mutation of the transthyretin gene (chr 18q). FAP is secondary to endoneurial amyloid deposits and are characterized by a slowly progressive sensory, motor and autonomic. FAP is the most severe hereditary polyneuropathy of the adult are irreversible and fatal within 5 to 12 years from onset. Most frequent mutation of TTR gene is located on the second exon; but more than 100 mutations have been reported. Prevalence of FAP is 1 per 1 million inhabitants. They have been reported until 1990s' in four endemic areas North of Portugal, Sweden, Japan and Majorca. In these areas, diagnosis is facilitated because of the stereotypical presentation : a length-dependent polyneuropathy with predominant involvement of thermal and pain sensations and autonomic dysfunction, early onset in the third decade and a predominant Met30 TTR mutation. Positive family history is frequent 85% (one of the parents is affected). Diagnosis requires detection of TTR mutation by molecular biology (blood sample) and characterization of amyloid deposit on labial salivary gland biopsy.

NCT ID: NCT03372174 Completed - Clinical trials for Cardiopulmonary Bypass

Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery

VECAR
Start date: January 10, 2018
Phase: N/A
Study type: Interventional

The main objective of this study is to measure the incidence of postoperative infections in 2 groups of patients: one group of patients ventilated and one group of patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate that the incidence of postoperative infections is significantly lower in patients ventilated during cardiopulmonary bypass.