Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine whether disinvestment in hydroxyl-ethyl starches (HES) for patients undergoing cardiac surgery was safe and effective.


Clinical Trial Description

Fluid replacement therapy is administered to patients requiring volume resuscitation following significant blood loss, or for maintenance fluid requirements. Severe blood loss can lead to anemia, reduced oxygen carrying capacity, and organ failure. Options for fluid replacement include red blood cell transfusion, colloids such as hydroxyethyl starches (HES), albumin, and gelatin as well as crystalloids such as normal saline and Ringer's lactate. Until recently, use of HES at the London hospitals and other major health sciences centers was concentrated in cardiac surgery patients and non-critically ill perioperative patients. In April 2013, the London Health Sciences Centre (LHSC) opted to discontinue the use of HES altogether, based on evidence suggesting that HES may be harmful compared to alternative fluid therapies.

The decision to disinvest in HES became effective on April 2, 2013. The hospitals no longer purchased HES, and clinicians used alternative fluids for volume resuscitation. Alternatives available at the hospitals included Ringer's lactate, normal saline, and albumin. All HES product was removed from patient care areas.

The investigators will perform a before/after analysis of the impact of HES disinvestment using a retrospective observational cohort study design, employing data obtained from administrative and clinical databases. Exposure to HES before disinvestment will be assumed to be 100% of cardiac surgical patients, and, after a washout period surrounding the time of disinvestment, exposure to HES will be assumed to be 0% after disinvestment.

The study population will be defined retrospectively in terms of the intervention received and the time period of the intervention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02329158
Study type Observational
Source Lawson Health Research Institute
Contact
Status Completed
Phase
Start date May 2015
Completion date April 2018

See also
  Status Clinical Trial Phase
Terminated NCT04293744 - Acute Kidney Injury After Cardiac Surgery N/A
Completed NCT01184521 - Masimo CO-Oximeter Study Phase 0
Completed NCT05537168 - Bayesian Networks in Pediatric Cardiac Surgery
Completed NCT04269109 - Opioid Sparing Pain Management Strategy
Completed NCT05737147 - Comparison of the Accuracy and Precision of a Zero Heat Flux Thermometer (SpotOn) Versus Pulmonary Artery Temperature.
Completed NCT04911413 - Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery Phase 4
Recruiting NCT02580292 - Diagnostic Accuracy of Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury .
Completed NCT02457572 - Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition N/A
Completed NCT00997217 - The Effect of Remote Ischemic Preconditioning in the Cardiac Surgery Phase 1
Recruiting NCT05454735 - Glycemic Variability and Autonomic Nervous System in Cardiac Surgery Patients
Completed NCT01169441 - Lead Extract Study N/A
Completed NCT00336908 - Inflammatory Responses to Lipid Emulsions in Children Before and After Open Heart Surgery Phase 2/Phase 3
Terminated NCT05308589 - CPPF After General Cardiac Surgery N/A
Recruiting NCT03163238 - Dexmedetomidine and the Inflammatory Response in Pediatric Cardiac Surgery Phase 2
Completed NCT01029314 - Pilot Study of the Genius(TM)2 Tympanic Thermometer in Cardiac Patients Requiring Cardiopulmonary Bypass N/A
Completed NCT00459082 - A Pharmacokinetic Study of Dexmedetomine in Infants Phase 1
Completed NCT00122018 - An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery Phase 2
Terminated NCT03709693 - Clinical Outcomes in Patients Treated With SternaLock Blu
Completed NCT03976947 - Impact of Lung Recruitment Maneuvers on Driving Pressure in Cardiac Surgery
Completed NCT02398019 - Clinical Trial to Evaluate the Use of an Adsorption Membrane (oXiris®) During Cardiopulmonary Bypass Surgery N/A