Diabetic cardiovascular Autonomic Neuropathy in patients undergoing major abdominal and cardiothoracic Surgery

Completed

Conditions: diabetes
neuropathy
10012653
10007963

Registration Number: NL-OMON44422

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

diabetes mellitus
planned for cardio-thoracic surgery or major gastro-intestinal surgery

Exclusion Criteria

Parkinsons disease
Pure autonomic failure
Multiple system atrophy with autonomic failure (Shy-Drager syndrome)
Addison*s disease and hypopituitarism
Pheochromocytoma
Peripheral autonomic neuropathy (e.g., amyloid neuropathy, idiopathic autonomic neuropathy)
Known cardiomyopathy
Extreme left ventricle hypertrophy
Ejection fraction < 30%

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The incidence of DAF in this population<br /><br>- The relation between the stage of autonomic failure and hemodynamic changes</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Ejection fraction postoperative compared to preoperatively in patients<br /><br>undergoing cardiac surgery.<br /><br>- Mean glucose during surgery, glucose increase during surgery, hyperglycaemia<br /><br>(>10 mmol/l) during surgery<br /><br>- Plasma creatinine difference before and day 0, 1 and 2 after surgery<br /><br>- Length of ICU and/or in-hospital stay<br /><br>- Length of inotropic dependent hours after surgery<br /><br>- In-hospital mortality < 30 days after surgery<br /><br>- Duration of DM<br /><br>- Presence of other DM related complications<br /><br>o Peripheral neuropathy (assessed with the Semmes-Weinstein test and tuning<br /><br>fork)<br /><br>o Presence of micro-albuminuria (from treating physician)<br /><br>o Retinopathy (based on last visit to ophthalmologist<br /><br>- Relation between DM related complications and stage of CAN<br /><br>- Difference in baroreflex sensitivity awake and under anaesthesia</p><br>