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Enhanced recovery protocols in cardiac surgery protocols

Efficacy of enhanced recovery protocols implementation in cardiac surgery. Randomized clinical trial - ERACSE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
RPCEC
Registry ID
RPCEC00000304
Enrollment
84
Registered
2019-11-20
Start date
2019-12-02
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease, valvular and aortic diseases

Interventions

Group I - Enhanced Recovery After Surgery protocol (Experimental): Protocol actions are: 1. Nutrition screening and optimization must be done during preoperative period, if the patient have bad nutri
he will be send to nutritional specialist for correct optimization 2. Clinical optimization: Correction of Hemoglobin level: more than 12 g/dl for women and 13 g/dl for men. Respiratory physiotherapy
Clinical Protocols
Thoracic Surgery
Perioperative Period
Perioperative Care
Peri-operative care protocol

Sponsors

Hermanos Ameijeiras Hospital
Lead Sponsor
Not applicable
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Obtain Informed consent 2. Patient without prior cardiac surgery. 3. Functional classification by NYHA or Canadian society in grade I, II or III. 4. Cardiac ejection fraction more than 45 %. 5. Absent of symptomatic arrhythmias. 6. Alert and without neurological dysfunction. 7. Urinary output more than 0.5 ml/Kg body weight, with creatinin level less than 132 mmol/l. 8 Absent of lung congestion sing in the thoracic X-ray.

Exclusion criteria

Exclusion criteria: 1. Urgent or emergent cardiac surgery. 2. Acute myocardial infarction (less than 7 days) or recently (between 7 and 30 days). 3. Third degree of atrial - ventricle blockade. 4. Sing of Cardiac failure. 5. Preoperative use of inotropic drugs or mechanical support. 6. Obstructive lung diseases. 7. Patients with Coagulations disorders. 8. Patients with diagnosis of any diseases resulting in decrease of gastric empty, as Diabetes, peptic ulcer, pylorus stenosis or gastric tumor.

Design outcomes

Secondary

MeasureTime frame
1. Adherence to the ERAS protocol (If when 75% (15 of 21) of the recommended actions in the study group are met). Measurement time: 72 hours after surgery. 2. Orotracheal extubation time (Time elapsed, in hours, from the end of the surgical intervention until the orotracheal extubation). Measurement time: At orotracheal extubation 3. Enteral nutrition time (Time elapsed, in hours, from the end of the surgical intervention until the oral feeding route is established). Time: at the time of establishing oral feeding. 4. Total intraoperative-BHTI and postoperative-BHTP water balance (Amount of volume, quantified in milliliters, to be administered to the patient during the intraoperative and postoperative periods). Measurement time: at the end of the intraoperative and postoperative periods 5. Time of postoperative mobilization-TMP (Time elapsed, in hours, from the end of the surgical intervention until the patient is seated). Measuring time: when the patient sits 6. Postoperative analgesia (Intensity of pain, evaluated verbally, according to visual analog scale (VAS) from zero to ten points). Measurement time: after the patient has been extubated, on an hourly basis, in the first three hours, at six hours, 12 hours, 24, 48 and 72 hours. 7. Opioid consumption (Total dose of opioids (mg) intravenously, which is needed in each patient to achieve adequate analgesia during the perioperative period). Measurement time: at the end of the perioperative period 8. Inotropic drug use (Yes, No. As required inotropic drugs to achieve hemodynamic stability). Measurement time: Upon discharge from the ICU 9. Early hospital readmission (Yes, No. As required by a re-entry of the patient after hospital discharge, for any reason). Measurement time: 30 days after surgery. 10. Level of satisfaction (High if the affirmative answers to the questions are between 90 and 100%, Quite satisfied if the affirmative answers to the questions are between 80 and 89%, Satisfied if the affirmative answers t

Primary

MeasureTime frame
1. Perioperative complications (immediate and mediated intraoperative and postoperative). Measurement time: 30 days after surgery. For this, they will be measured as: Intraoperative (Complications that arise from the beginning of the anesthetic procedures until the patient,is transferred to the ICU after the operation), Immediate postoperative (Complications that occur from the moment the patient arrives at the ICU until the first 72 hours after the surgical intervention), Postoperative mediations (Complications that occur from 72 hours after the surgery and until the patient is discharged from hospital) and Late postoperative (Complications that occur from hospital discharge up to 30 days after the surgical procedure) 2. Stay in the Intensive Care Unit (Time, measured in hours, from the entrance to the Intensive Care Unit (ICU) until the exit from the ICU). Measurement time: Upon discharge from the ICU 3. Hospital stay (Time, measured in days, from the date of entry to the ward until hospital discharge). Measurement time: at hospital discharge

Countries

Cuba

Contacts

Public ContactMaria Aguero Martinez

Hermanos Ameijeiras Hospital

osly@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026