2023-509071-16-00招募中4 期
Renal Outcomes in the early use of vasopressin in the treatment of septic shock
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- 30% reduction of patients satisfying the criteria for CRRT within the study group.
研究概览
简要总结
The primary objective of the study is to verify whether the earlier association of vasopressin and norepinephrine determines variations in terms of the use of renal function replacement techniques in the first 7 days of hospitalization in the Intensive Care Unit (ICU), compared to patients in whom the vasopressin is added only when norepinephrine reaches a higher dosage.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from septic shock hospitalized in an intensive setting within 24 hours of clinical diagnosis
- •Capable of expressing informed consent to treatment
- •Aged over 18 years and under 80 years of age
- •Male and female
- •Norepinephrine dosage equal to or greater than 0.25 mcg/kg/min according to the patient's ideal weight (IBW)
排除标准
- •Patients in the absence of consent to participate in the study and to the processing of personal and particular data
- •Patients with allergy/intolerance to the drugs used in the study
- •Pregnant patients
- •Patients who need to start renal replacement treatment within 24 hours of admission to the ICU for dialysis emergencies that cannot be deferred
- •Patients with a history of end-stage renal failure or already undergoing dialysis treatment (CKD stages 4 and 5, with glomerular filtration < 30 ml/min)
- •Norepinephrine dosage equal to or greater than 0.5 mcg/kg/min according to the patient's ideal weight (IBW) at enrollment time
- •Single kidney patients
- •Patients with bilateral renal hypoplasia
- •Patients undergoing kidney transplant
- •Patients undergoing haemoperfusion with an adsorbent cartridge for bacterial endotoxin
- •Patients under 18 years of age or over 80 years of age
- •Patients who died within the first 24 hours of admission to the ICU
- •Patients requiring a norepinephrine dosage lower than 0.25 mcg/kg/min in the first 24 hours of hospitalization in the ICU
- •Patients with recent acute coronary syndrome (within the previous 7 days)
结局指标
主要结局
30% reduction of patients satisfying the criteria for CRRT within the study group.
30% reduction of patients satisfying the criteria for CRRT within the study group.
次要结局
- Reduction of maximum KDIGO class reached in the first 7 days of hospitalization
- Evaluation of renal perfusion using the CEUS method carried out within 24 hours of enrollment and 72 hours after the first evaluation (in terms of the presence of ischemic areas, their number and size
- Water balance 24, 48, 72 hours after admission to the ICU
- Number of patients meeting criteria for RRT during ICU stay
- Number of patients who develop AF, atrial flutter or PSVT lasting more than 30 minutes and who require the introduction of new drugs for rate or rhythm control or electrical cardioversion within 24 hours of arrhythmic onset
- Number of patients who present intestinal ischemia or extremity ischemia during the infusion of vasoactive drugs or within 3 days after the end of the administration of the aforementioned drugs
- Length of stay in ICU and mortality at 28 and 90 days
研究者
Lorenzo Giuntoli
Scientific
Azienda Unita Sanitaria Locale Di Bologna
研究点 (1)
Loading locations...
相似试验
招募中
4 期
Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic ShockRenal Function ReplacementSeptic ShockNCT06471231Azienda Usl di Bologna264
招募中
1 期
Renal Outcomes in the early use of vasopressin in the treatment of septic shockMedDRA version: 20.0Level: PTClassification code: 10040070Term: Septic shock Class: 100000004862Septic shockCTIS2023-509071-16-00Azienda Unita Sanitaria Locale Di Bologna242
已完成
不适用
Vasopressin in Intraabdominal Pressure ElevationIntracranial Pressure IncreaseAbdominal Compartment SyndromeNCT03707054The Cleveland Clinic16
已完成
2 期
Effect of vasopressin and norepinephrine on Renal function of patients undergoing CABG in Emam Khomeini hospital of ArdabilOpen heart sergury.Ischaemic heart diseasesI20-25IRCT201412054256N4Ardabil University of Medical Sciences120
已完成
不适用
Study to Evaluate if the Drug Vasopressin Protects the Kidneys for Patients Undergoing Liver TransplantLiver FailureNCT00886262Medical University of South Carolina18