Clinical Trials Logo

Clinical Trial Summary

The fracture of the upper extremity of the femur (FESF) is one of the most common fractures in traumatology. In France, FESF affects more than 65,000 individuals per year and could involve up to 150,000 people per year by 2050, due to the increase in life expectancy of the population. The main risk factors for the occurrence of ESF are: age, gender, osteoporosis, undernutrition, gait and balance disorders. The main risk factors for death identified by the French Society of Orthopaedic Surgery and Geriatrics after surgery for ESF are: a delay between the trauma and surgery of more than 48 hours, poorly tolerated preoperative anemia or a hemoglobinemia of less than 8 g/dl, absence of antibiotic prophylaxis, postoperative acute renal failure, and discontinuation of antiaggregant treatments in the case of coronary disease. Post-operative Acute Kidney Injury (AKI) is one of the risk factors for mortality after surgery for ESF. AKI is an impairment of normal kidney function, and in general, AKI is a major issue in the management of patients undergoing surgery. In the short term, it increases the length of stay of patients, and the number of admissions to continuing care. AKI increases post-operative mortality by more than 50%. However, because of the complications associated with vascular filling, the use of vasoconstrictor drugs, such as ephedrine, phenylephrine, and especially norepinephrine, is increasingly common. Compared with other catecholamines, norepinephrine has been shown to be more effective in increasing cardiac output. Moreover, unlike bolus administration of ephedrine or phenylephrine, which favor the occurrence of blood pressure peaks and valleys, norepinephrine, administered as a continuous infusion, allows blood pressure to be maintained in a narrower range. The challenge is to implement a strategy to reduce their frequency. Intraoperative arterial hypotension is one of the risk factors on which investigators can intervene thanks to the "preventive" administration of noradrenaline in continuous infusion, started before or immediately after the induction of anesthesia. However, the "preventive" use of norepinephrine may favor the occurrence of AKI in hypovolemic patients (fracture and surgery-related bleeding, prolonged fasting) by reducing renal blood flow. Our primary objective is to compare the risk of AKI occurrence during a "preventive" norepinephrine administration strategy with a target MAP ≥65 mmHg compared with that observed in response to a vasoconstrictor-only administration strategy in response to the occurrence of arterial hypotension episodes. Secondary objectives are to evaluate the potential interactions of this preventive strategy with other risk factors for postoperative AKI.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05566132
Study type Observational
Source Fondation Hôpital Saint-Joseph
Contact
Status Completed
Phase
Start date August 9, 2022
Completion date September 11, 2023

See also
  Status Clinical Trial Phase
Completed NCT01946113 - Mineral-Homeostasis in Continuous Renal Replacement Therapy N/A
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Withdrawn NCT00993733 - Assessing the Impact of Two Methods of Continuous Veno-venous Hemodiafiltration on Time Nursing Work in Intensive Care N/A
Terminated NCT00978354 - Furosemide in Early Acute Kidney Injury Phase 2/Phase 3
Completed NCT00120263 - Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma N/A
Completed NCT04799600 - The Effect of the Severity of COVID-19 Disease on the Incidence of Acute Renal Failure in ICU
Recruiting NCT04334707 - Kidney Precision Medicine Project
Completed NCT02858531 - Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics
Recruiting NCT05282732 - Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients
Completed NCT01467466 - Prevention of Serious Adverse Events Following Angiography Phase 3
Completed NCT01979042 - Urinary Markers for Unilateral Kidney Obstruction N/A
Completed NCT01280617 - Low Dose Thymoglobin in Renal Transplant Patients N/A
Completed NCT00780351 - Dosing Vancomycin in Patients on Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f) N/A
Completed NCT00971971 - Prevention of Intradialytic Hypotension in Acute Kidney Injury Patients N/A
Completed NCT00076219 - Acute Renal Failure Trial Network (ATN) Study Phase 3
Recruiting NCT04599569 - Influence of Renal Replacement TherApy on Indirect Calorimetry
Completed NCT03727204 - Acute Kidney Injury After Cardiac Surgery: Novel Ultrasound Techniques for Prediction of Acute Kidney Injury
Completed NCT06005896 - A Clinical Model for Dialysis Discontinuation in AKI
Completed NCT03627884 - Outcomes of the Use of Sodium Bicarbonate (8.4%) Solution as a Catheter Lock Solution to Prevent Hemodialysis Catheter Loss Due to Lumen Clot Formation Phase 4
Completed NCT03004950 - Biomarker Effectiveness Analysis in Contrast Nephropathy (BEACON)