|- candidate number||21030|
|- NTR Number||NTR4976|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-nov-2014|
|- Secondary IDs||2014-242 NL49521.018.14|
|- Public Title||DANS study - diabetic autonomic neuropathy in patients undergoing surgery|
|- Scientific Title||Diabetic cardiovascular autonomic neuropathy in patients undergoing major gastrointestinal and cardiothoracic surgery|
|- hypothesis||patients with diabetic cardiovascular autonomic neuropathy are more prone to hypotension during surgery and therefore require more inotropic/vaspressor medication perioperatively|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus, Surgery, Cardiovascular autonomic neuropathy|
|- Inclusion criteria||• 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
|- Exclusion criteria||• 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
• 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
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-okt-2014|
|- planned closingdate||1-dec-2015|
|- Target number of participants||90|
|- Interventions||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. |
|- Primary outcome||- 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.
|- Secondary outcome||- Ejection fraction postoperative compared to preoperatively in patients undergoing cardiac surgery, (pre- and postoperative transthoracic/transesophageal ultrasound images are made for standard care).
- Mean glucose during surgery, glucose increase during surgery, hyperglycaemia (>10 mmol/l) during surgery (measured for standard care).
- Plasma creatinine difference before and day 0, 1 and 2 after surgery (when measured for standard care).
- Length of ICU and/or in-hospital stay
- Length of inotropic dependent hours after surgery
- In-hospital mortality < 30 days after surgery
- Duration of DM
- Presence of other DM related complications
o Peripheral neuropathy (assessed with the Semmes-Weinstein test and tuning fork)
o Presence of micro-albuminuria (from treating physician)
o Retinopathy (based on last visit to ophthalmologist)
- Relation between DM related complications and stage of CAN
|- Timepoints||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|
|- Trial web site|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Jorinde Polderman|
|- CONTACT for SCIENTIFIC QUERIES|| Jorinde Polderman|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Anesthesiology|
(Source(s) of Monetary or Material Support)
|- Brief summary||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.
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?
|- Main changes (audit trail)|
|- RECORD||24-nov-2014 - 20-aug-2017|