Disinvestment in Hydroxyl-ethyl Starches (HES) for Cardiac Surgery

NCT02329158 | Completed

• 1 other identifier: 105755
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  Acute hospital length of stay (in days) following cardiac surgery

  Following cardiac surgery (on average approximately 10 days)

Secondary Outcomes (6)

• Rates of transfusion

  During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)

• Rates of transfusion

  During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)

• Kidney Injury

  During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)

• Renal Replacement Therapy

  During or after cardiac surgery, prior to hospital discharge (on average approximately 10 days)

• Cost of care

  During the acute phase of the hospital stay (on average approximately 10 days)

Study Arms (2)

Arm: Exposed: Hydroxyethyl starch

Cardiac surgical patients exposed to 6% hydroxyethyl starch (130/0.4).

Drug: 6% hydroxyethyl starch

Arm: Unexposed: Hydroxyethyl starch

Cardiac surgical patients not exposed to 6% hydroxyethyl starch (130/0.4).

Interventions

6% hydroxyethyl starch DRUG

Also known as: Voluven (Fresenius Kabi)

Arm: Exposed: Hydroxyethyl starch

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The proposed study population includes adult patients (age \>/= 18) who underwent coronary artery bypass surgery (CABG) with or without valve surgery at the London Health Sciences Centre.

You may qualify if:

• The London Health Sciences Centre disinvested in hydroxyethyl starches on April 2, 2013. The study population will include individuals undergoing cardiac surgery and discharged from hospital in one of two eras:
• Era 1 (365 days prior to disinvestment in HES): the time period between April 1, 2012 and March 31, 2013, or
• Era 2 (365 days following disinvestment in HES): the time period between June 1, 2013 and May 31, 2014 (NB: after a 2-month washout period to ensure all HES supplies had been exhausted).
• Specifically, the study population will be comprised of patients who underwent the following cardiac surgical procedures:
• Coronary artery bypass graft only
• Coronary artery bypass graft with aortic valve replacement
• Coronary artery bypass graft with aortic valve repair
• Coronary artery bypass graft with mitral valve replacement
• Coronary artery bypass graft with mitral valve repair
• Coronary artery bypass graft with a valve surgical procedure (replacement and/or repair) involving up two valves

You may not qualify if:

• Individuals with any portion of the acute length of stay spanning the washout period (April 1, 2013 to May 31, 2013) will be excluded. Specifically, the following patients will be excluded:
• Patients admitted prior to April 1, 2013 that remained in hospital on April 1, 2013.
• Patients admitted during the washout period (April 1, 2013 to May 31, 2013) that remained in hospital on May 31, 2013.
• Patients admitted and discharged during the washout period.
• Individuals enrolled in the randomized controlled clinical trial entitled, "VolulyteTM in Cardiac Surgery" (ClinicalTrials.gov Identifier: NCT01553617) will be excluded from the cohort. The purpose of this study was to assess the efficacy and safety of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) compared to 5% Human Serum Albumin as volume replacement therapy in elective open-heart surgery in adult patients on cardiopulmonary bypass. Individuals enrolled in the trial were randomized to priming of the cardiopulmonary bypass machine and volume therapy as necessary with either Volulyte or Human Serum Albumin. The study began in October 2012 and was completed in January 2014, with a total enrolment of 133 patients. The approximate number enrolled at LHSC was 30. Because the study period overlaps with that of the pre- and post- disinvestment eras, individuals enrolled in this study will be excluded from the retrospective cohort.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Western University, Canada: collaborator

Related Publications (1)

• Hong M, Jones PM, Martin J, Kiaii B, Arellano R, Cheng D, John-Baptiste AA. Clinical impact of disinvestment in hydroxyethyl starch for patients undergoing coronary artery bypass surgery: a retrospective observational study. Can J Anaesth. 2019 Jan;66(1):25-35. doi: 10.1007/s12630-018-1245-5. Epub 2018 Nov 8.

  PMID: 30411246 DERIVED

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives; HES 130-0.4

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 31, 2014
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11