patients with diabetic cardiovascular autonomic neuropathy are more prone to hypotension during surgery and therefore require more inotropic/vaspressor medication perioperatively
ID
Bron
Verkorte titel
Aandoening
cardiovascular autonomic neuropathy
Diabetes mellitus
Surgery
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- The prevalence of CAN in this surgical population
- The relation between the stage of CAN and hemodynamic changes*
* Hemodynamic changes are defined as:
- Postinduction hypotension: mean arterial pressure <55 mmHg measured within first 10 minutes after start induction.
- Postinduction mean arterial pressure; lowest mean blood pressure measured within first 10 minutes after start induction.
- Postinduction blood pressure change: difference between highest mean arterial pressure before induction and lowest after induction before intubation.
- Postinduction heart rate change: difference between minimum heart rate after induction and maximum heart rate before induction.
- Maximum heart rate during tracheal intubation.
- Maximum mean arterial blood pressure during tracheal intubation.
- Perioperative inotropics; definition: total dose of inotropics (mcg/kg/hour) during surgery. Maximal dose during surgery (mcg/kg/hour)
- Perioperative hypotension: mean arterial pressure < 55 mmHg at any time during the procedure.
- Postoperative inotropics; definition: total dose (mcg/kg/hour) of inotropics after surgery.
Achtergrond van het onderzoek
Diabetes mellitus (DM) is associated with a two- to threefold increase in perioperative cardiovascular morbidity and mortality, compared to patients without DM. In addition to well-known complications of DM, diabetic autonomic neuropathy may contribute to the perioperative cardiovascular morbidity and mortality. Cardiovascular autonomic neuropathy (CAN) is one of the most serious forms of diabetic autonomic neuropathy. Patients with CAN are at increased risk of perioperative hemodynamic instability, cardiopulmonary arrest, (postoperative) silent myocardial infarction and postoperative mortality.
There are different tests to determine CAN. Ewing’s battery of tests are simple, inexpensive and reliable bedside tests for CAN. If these bedside tests can help us to predict perioperative cardiovascular instability in patients with DM, it might be important to assess patients with DM for the presence of CAN during their preoperative screening, for more vigilant perioperative management.
Objective:
1) What is the prevalence of CAN in patients with DM scheduled for major abdominal / cardiothoracic surgery?
2) Does the severity of CAN relate to perioperative hemodynamic changes?
Doel van het onderzoek
patients with diabetic cardiovascular autonomic neuropathy are more prone to hypotension during surgery and therefore require more inotropic/vaspressor medication perioperatively
Onderzoeksopzet
Day before surgery: autonomic function tests
Day of surgery: standardized induction. Collection of perioperative data via chart review
Days after surgery: collection of postoperative data via chart review
Onderzoeksproduct en/of interventie
On the day before surgery, patients will be subjected to 5 non-invasive tests to assess diabetic CAN, there will be no invasive test performed for study purposes.
Publiek
Meibergdreef 9-15
Amsterdam 1115AZ
The Netherlands
020-5669111 pager 57431
j.a.polderman@amc.uva.nl
Wetenschappelijk
Meibergdreef 9-15
Amsterdam 1115AZ
The Netherlands
020-5669111 pager 57431
j.a.polderman@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Willing and able to give written informed consent
• (DM type 1 or type 2)
• Scheduled for major gastro-intestinal- or cardiothoracic surgery
• Age 18-85 years
• Sinus rhythm
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Parkinson’s disease
• Pure autonomic failure (formerly called idiopathic orthostatic hypotension)
• Multiple system atrophy with autonomic failure (formerly called Shy-Drager syndrome)
• Addison’s disease and hypopituitarism
• Pheochromocytoma
• Peripheral autonomic neuropathy (e.g., amyloid neuropathy, idiopathic autonomic neuropathy)
• known cardiomyopathy
• Extreme left ventricle hypertophy21
• Ejection fraction < 30%21
• Proven or suspected allergy for any of the medication used during induction of anaesthesia
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4706 |
NTR-old | NTR4976 |
Ander register | NL49521.018.14 : 2014-242 |