THERAPY OF ALCOHOL-WITHDRAWAL SYNDROME IN INTENSIVE-CARE UNIT PATIENTS FOLLOWING TRAUMA - RESULTS OF A PROSPECTIVE, RANDOMIZED TRIAL

Objectives: To assess the effect of three different alcohol withdrawal therapy regimens in traumatized chronic alcoholic patients with respe ct to the duration of mechanical ventilation and the frequency of pneu monia and cardiac disorders during their intensive care unit (ICU) sta y. Design: A prospective, randomized, blinded, controlled clinical tri al. Setting: A university hospital ICU. Patients: Multiple-injured alc ohol-dependent patients (n = 180) transferred to the ICU after admissi on to the emergency room and operative management. A total of 180 pati ents were included in the study; however, 21 patients were excluded fr om the study after assignment. Interventions: Patients who developed a ctual alcohol withdrawal syndrome were randomized to one of the follow ing treatment regimens: flunitrazepam/clonidine (n = 54); chlormethiaz ole/haloperidol (n = 50); or flunitrazepam/haloperidol (n = 55). The n eed for administration of medication was determined, using a validated measure of the severity of alcohol withdrawal (Revised Clinical Insti tute Withdrawal Assessment for Alcohol Scale). Measurements and Main R esults: The duration of mechanical ventilation and major intercurrent complications, such as pneumonia, sepsis, cardiac disorders, bleeding disorders, and death, were documented. Patients did not differ signifi cantly between groups regarding age, Revised Trauma and Injury Severit y Score, and Acute Physiology and Chronic Health Evaluation II score o n admission. In all except four patients in the flunitrazepam/clonidin e group, who continued to hallucinate, the Revised Clinical Institute Withdrawal Assessment for Alcohol Scale decreased to <20 after initiat ion of therapy, ICU stay did not significantly differ between groups ( p = .1689). However, mechanical ventilation was significantly prolonge d in the chlormethiazole/haloperidol group (p = .0315) due to an incre ased frequency of pneumonia (p = .0414). Cardiac complications were si gnificantly (p = .0047) increased in the flunitrazepam/clonidine group . Conclusions: There was some advantage in the flunitrazepam/clonidine regimen with respect to pneumonia and the necessity for mechanical ve ntilation. However, four (7%) patients had to be excluded from the stu dy due to ongoing hallucinations during therapy. Also, cardiac complic ations were increased in this group. Thus, flunitrazepam/haloperidol s hould be preferred in patients with cardiac or pulmonary risk. Further studies are required to determine which therapy suits individual pati ents. A symptom-orientated patient approach rather than one standard t herapy should be considered.