Feasibility of early waking cardiac arrest patients whilst receiving therapeutic hypothermia: The therapeutic hypothermia and early waking (THAW) trial.

AIM: To determine the safety and feasibility of an early (12 h) waking and extubation protocol for out-of-hospital cardiac arrest (OHCA) patients receiving targeted temperature management (TTM). METHODS: This was a single-centre, prospective, non-randomised, observational, safety and feasibility pilot study which included successfully resuscitated OHCA patients, of presumed cardiac cause. Inclusion criteria were: OHCA patients aged over 18 years with a return of spontaneous circulation, who were going to receive TTM33 (TTM at 33 °C for 24 h and prevention of hyperthermia for 72 h) as part of their post cardiac arrest care. Clinical stability was measured against physiological and neurological parameters as well as clinical assessment. RESULTS: 50 consecutive patients were included (median age 65.5 years, 82% male) in the study. Four (8%) patients died within the first twelve hours and were excluded from the final cohort (n = 46). Twenty-three patients (46%) were considered clinically stable and suitable for early waking based on the intention to treat analysis; 12 patients were extubated early based on a variety of clinical factors (21.4 ± 8.6 h) whilst continuing to receive TTM33 with a mean core temperature of 34.2 °C when extubated. Of these, five patients were discharged from the intensive care unit (ICU) <48 h after admission with a mean ICU length of stay 1.8 ± 0.4 days. Twenty-eight patients (56%) were discharged from the ICU with a modified Rankin Score of 0-2. The overall intra-hospital mortality was 50% (n = 25). CONCLUSIONS: It is safe and feasible to wake selected comatose OHCA patients at 12 h, allowing for earlier positive neuro-prognostication and reduced ICU stay.

Is It Feasible and Safe to Wake Cardiac Arrest Patients Receiving Mild Therapeutic Hypothermia After 12 Hours to Enable Early Neuro-Prognostication? The Therapeutic Hypothermia and Early Waking Trial Protocol.

Mild therapeutic hypothermia (MTH 33°C) post out-of-hospital cardiac arrest (OHCA) is widely accepted as standard of care. However, uncertainty remains around the dose and therapy duration. OHCA patients are usually kept sedated±paralyzed and ventilated for the first 24-36 hours, which allows for targeted temperature management, but makes neurological prognostication challenging. The aim of this study is to investigate the feasibility and safety of assessing the unconscious OHCA patient after 12 hours for early waking/extubation while continuing to provide MTH for 24 hours, and fever prevention for 72 hours by using an intravenous temperature management (IVTM) system and established conscious MTH anti-shiver regimens. This is a single-center, prospective, non-randomized observational study that will compare the results of early awakening (at 12 hours) with historical controls. A total of 50 consecutive unconscious survivors of OHCA, treated with MTH, who meet the Therapeutic Hypothermia and eArly Waking (THAW) inclusion criteria will be enrolled. The patient will receive MTH by using IVTM. After 12 hours of MTH, patients will be assessed by using strict clinical criteria to determine suitability for early waking and extubation. Once awake and extubated, MTH will continue for 24 hours with skin counter-warming and anti-shiver regimen followed fever prevention up to 72 hours. All patients will have serial electroencephalogram (EEG), somatic sensory potential, and neuro-biomarkers performed on admission to intensive care unit, 6 and 12 hours, then every 24 hours until 72 hours. The study has been approved by the National Research Ethics Service, Health Research Authority.

Fenoldopam infusion for renal protection in high-risk cardiac surgery patients: a randomized clinical study.

OBJECTIVE: The purpose of this study was to evaluate the renoprotective effects of fenoldopam in patients at high risk of postoperative acute kidney injury undergoing elective cardiac surgery requiring cardiopulmonary bypass. DESIGN: A double-blind randomized clinical trial. SETTING: Hospital. PARTICIPANTS: One hundred ninety-three patients. INTERVENTIONS: Patients undergoing cardiac surgery were randomly assigned to receive a continuous infusion of fenoldopam, 0.1 microg/kg/min (95 patients), or placebo (98 patients) for 24 hours. Patients were included if at least 1 of the following risk factors was present: preoperative serum creatinine > or =1.5 mg/dL, age >70 years, diabetes mellitus, or prior cardiac surgery. Serum creatinine and urinary output were measured at baseline (T1), 24 hours (T2), and 48 hours after surgery (T3). Acute kidney injury was defined as a postoperative serum creatinine level of > or =2 mg/dL with an increase in serum creatinine level of 0.7 mg/dL or greater from preoperative to maximum postoperative values. MEASUREMENTS AND MAIN RESULTS: Acute kidney injury developed in 12 of 95 (12.6%) patients receiving fenoldopam and in 27 of 98 (27.6%) patients receiving placebo (p = 0.02), whereas renal replacement therapy was started in 0 of 95 and 8 of 98 (8.2%) patients, respectively (p = 0.004). Serum creatinine was similar at baseline (1.8 +/- 0.4 mg/dL v 1.9 +/- 0.3 mg/dL) in the fenoldopam and placebo groups but differed significantly (p < 0.001 and p < 0.001) 24 hours (1.6 +/- 0.2 mg/dL v 2.5 +/- 0.6 mg/dL) and 48 hours (1.5 +/- 0.3 mg/dL v 2.8 +/- 0.4 mg/dL) after the operation. CONCLUSIONS: A 24-hour infusion of 0.1 mug/kg/min of fenoldopam prevented acute kidney injury in a high-risk population undergoing cardiac surgery.