- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05566132
Preventive Norepinephrine Infusion During Surgery for Upper Femoral Fracture and Post-operative Acute Renal Failure (NORAKI)
September 11, 2023 updated by: Fondation Hôpital Saint-Joseph
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
676
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Paris, France, 75014
- Groupe Hospitalier Paris Saint-Joseph
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
- Patient 18 years of age or older, hospitalized for a fracture of the upper end of the femur.
Description
Inclusion Criteria:
- Patient 18 years of age or older
- Patient hospitalized for a fracture of the upper end of the femur
- French speaking patient
Exclusion Criteria:
- Patient with severe or end-stage chronic renal disease preoperatively
- Patient with no anesthesia report in DxCare®.
- Patient who does not have an ICU report in DxCare®.
- Patients who did not have a creatinine measurement in the emergency room or in the postoperative period
- Patients who did not receive vasoconstrictors during surgery
- Patients who tested positive for, or were diagnosed with, SARS-COV 2 infection
- Patients under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patients who object to the use of their medical data in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk of acute renal failure with a "preventive" norepinephrine administration strategy
Time Frame: Day 2
|
This outcome corresponds to the incidence of acute renal failure defined as an increase in postoperative creatinine value to 1.5 times baseline or an increase of 26.5 mmol/L in blood creatinine from baseline.
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Day 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of the two strategies according to preoperative/operative risk factors
Time Frame: Day 2
|
This outcome corresponds to the presence/absence of preoperative risk factors
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Day 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pascal ALFONSI, MD, Fondation Hôpital Saint-Joseph
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. No abstract available.
- Ahuja S, Mascha EJ, Yang D, Maheshwari K, Cohen B, Khanna AK, Ruetzler K, Turan A, Sessler DI. Associations of Intraoperative Radial Arterial Systolic, Diastolic, Mean, and Pulse Pressures with Myocardial and Acute Kidney Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2020 Feb;132(2):291-306. doi: 10.1097/ALN.0000000000003048.
- Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. doi: 10.1001/jama.2009.1462.
- Dadure C, Marie A, Seguret F, Capdevila X. One year of anaesthesia in France: A comprehensive survey based on the national medical information (PMSI) database. Part 1: In-hospital patients. Anaesth Crit Care Pain Med. 2015 Aug;34(4):191-7. doi: 10.1016/j.accpm.2014.12.003. Epub 2015 Jun 30.
- Sykes L, Kalra PA, Green D. Comparison of impact on death and critical care admission of acute kidney injury between common medical and surgical diagnoses. PLoS One. 2019 Apr 11;14(4):e0215105. doi: 10.1371/journal.pone.0215105. eCollection 2019.
- Wood RJ, White SM. Anaesthesia for 1131 patients undergoing proximal femoral fracture repair: a retrospective, observational study of effects on blood pressure, fluid administration and perioperative anaemia. Anaesthesia. 2011 Nov;66(11):1017-22. doi: 10.1111/j.1365-2044.2011.06854.x. Epub 2011 Aug 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2022
Primary Completion (Actual)
September 9, 2022
Study Completion (Actual)
September 11, 2023
Study Registration Dates
First Submitted
September 30, 2022
First Submitted That Met QC Criteria
September 30, 2022
First Posted (Actual)
October 4, 2022
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NORAKI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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