Sepsis Clinical Trial - Hydrocortisone, Vitamin C, & Thiamine for

Status Completed

Clinical Trial Summary

In this prospective clinical study, the investigators compare the outcome and clinical course of consecutive septic participants treated with intravenous vitamin C, hydrocortisone, and thiamine (treatment group) with a control group treated in the investigators' ICU. The primary outcome is hospital survival. A propensity score is generated to adjust the primary outcome.There is 70 participants in each group.

Clinical Trial Description

A prospective randomized controlled trial is conducted.One hundred and forty severe sepsis or septic shock participants admit to the Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University from September 2017.The participants are divided into control group ( n = 70 ) and treatment group ( n = 70 ).The participants in both groups are treated according to "2016 international guidelines for management of sepsis and septic shock",and the participants in treatment group receive intravenous vitamin C, hydrocortisone, and thiamine. The participants in control group receive normal saline.The patients' clinical and demographic data, including age, sex, admitting diagnosis, comorbidities, requirement for mechanical ventilation, use of vasopressors, daily urine output, fluid balance after 24 and 72 h, length of ICU stay (LOS),and laboratory data (serum creatinine, White Blood Cell (WBC), platelet count, total bilirubin, procalcitonin(PCT), and lactate levels), are recorded.The primary outcome is hospital survival. Secondary outcomes include duration of vasopressor therapy,requirement for renal replacement therapy in patients with Acute kidney injury (AKI), ICU LOS, and the change in serum procalcitonin and Sepsis-Related Organ Failure Assessment (SOFA score) over the first 72 h. Summary statistics are used to describe the clinical data and are presented as means±SD, medians and interquartile range, or percentages as appropriate.Statistical analysis is performed with NCSS 11 (NCSS Statistical Software) and SPSS Statistics version 24 (IBM). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03258684
Study type	Interventional
Source	Zhujiang Hospital
Contact
Status	Completed
Phase	N/A
Start date	September 25, 2017
Completion date	February 2, 2019

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05095324` - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed	`NCT02714595` - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens	Phase 3
Completed	`NCT03644030` - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed	`NCT02867267` - The Efficacy and Safety of Ta1 for Sepsis	Phase 3
Completed	`NCT04804306` - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting	`NCT05578196` - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.	N/A
Terminated	`NCT04117568` - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed	`NCT03550794` - Thiamine as a Renal Protective Agent in Septic Shock	Phase 2
Completed	`NCT04332861` - Evaluation of Infection in Obstructing Urolithiasis
Completed	`NCT04227652` - Control of Fever in Septic Patients	N/A
Enrolling by invitation	`NCT05052203` - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated	`NCT03335124` - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock	Phase 4
Recruiting	`NCT04005001` - Machine Learning Sepsis Alert Notification Using Clinical Data	Phase 2
Recruiting	`NCT05217836` - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed	`NCT05018546` - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery	N/A
Completed	`NCT03295825` - Heparin Binding Protein in Early Sepsis Diagnosis	N/A
Not yet recruiting	`NCT06045130` - PUFAs in Preterm Infants
Not yet recruiting	`NCT05361135` - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia	N/A
Not yet recruiting	`NCT05443854` - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)	Phase 3
Not yet recruiting	`NCT04516395` - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock — HYVCTTSSS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms