Revisiones para Enhanced recovery protocols in cardiac surgery protocols | Registro Público Cubano de Ensayos Clínicos

--- 20 Noviembre 2019 - 10:02am por Gladys
+++ 21 Octubre 2020 - 1:43pm por lazara
-San Lazaro Street, between Belascoain and Marquez Gonzalez
+San Lazaro Street, between Belascoain and Marquez Gonzalez. Havana. Cuba
-/11/20
+/10/21
-/11/20
+/10/21

Revisión de 21 Octubre 2020 - 1:43pm

Enhanced recovery protocols in cardiac surgery protocols

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

ERACS

Scientific title:

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

Acronym of Scientific Title:

ERACSE

Secondary indentifying numbers:

VERSION 0.0 Number 2645

Issuing authority of the secondary identifying numbers:

Hermanos Ameijeiras Hospital

Source(s) of monetary or material support:

Hermanos Ameijeiras Hospital (HHA)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Maria

Midle name:

Oslaida

Last name:

Aguero Martinez

Medical Specialty :

PhD. MD. Second degree specialist in Anesthesiology

Affiliation:

Hermanos Ameijeiras Hospital

Postal address:

San Lazaro Street, between Belascoain and Marquez Gonzalez

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-58879035

Email address:

osly@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

02/12/2019

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Coronary artery disease, valvular and aortic diseases

Health condition(s) code:

Coronary Artery Disease

Heart Valve Diseases

Aortic Diseases

Thoracic Diseases

Coronary Disease

Vascular Diseases

Cardiovascular Diseases

Myocardial Ischemia

Heart Diseases

Arterial Occlusive Diseases

Arteriosclerosis

Intervention(s):

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 nutritional status (taking in to consideration body mass index less than 18.5 Kg/m2 , weigh lost more than 10% in the last 6 month, decreases in oral intake more than 50% in one week, albumin level less than 3 g/dL, lymphocytes account level less than 1 000 cells / mm3 (20 %) ; 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 one week previous surgery. Stop smoking and intake alcohol 4 weeks previous surgery. 3. Avoid bowel preparation. 4. The fasting time for solid food will be 6 hr 5. The fasting time for liquid will be 3 hr. The patients will receive 250 ml of Nutrial II (solution with high content of carbohydrates) 6. Preoperative education: All patient will received detailed explanation about perioperative pathways and educational brochure will be delivered. Intraoperative actions 1. Prophylactic antibiotic: cefuroxime 1.5 g, 60 min previously to the surgery. 2. Multimodal anesthesia/analgesic techniques, with a combination of general anesthesia, intercostal block and wound infiltration at the end of the surgery. Preventive analgesia: Gabapentin two hour previously to the surgery. Perfalgan 15 mg /kg of corporal body. 3. Lung protection strategy: low tidal volume (6-7 ml/kg), positive end expiratory pressure (5 mmhg) and alveolar recruitment manoeuvres. 4. Intraoperative goal-directed therapy (GDT) will be introduced to achieve total negative balance between 250 and 500ml. 5. Optimization of cardiopulmonary bypass: Total priming fluid reduction to less than 1500 ml, ultrafiltration and albumin infusion to maintain a stable plasma colloid osmotic pressure. 6. The Post-Operative Nausea and Vomiting (PONV) prophylaxis will be carried out through a multimodal approach: ondansetron will be administered in doses of 0.1 mg / kg body weight and dexamethasone in doses of 1 mg / kg body weight, both intravenously. Dexamethasone, too, will be used as an anti-inflammatory therapy. Everything will be administered before anesthesia Postoperative actions 1. PONV will be continuous. 2. Multimodal analgesia was described in the intraoperative period. 3. Postoperative goal-directed therapy. Hatmnan solution 1000 ml for 24 hour, and the same guide by hemodynamic objectives. 4. Early enteral nutritional therapy, after orotracheal extubation, 2 hr for liquids and 6 hr for solids foods. 5. Early mobilization, 6 hr after orotracheal extubation, lay the patient will be indicated. 6. Early remove catheter and drains, in the first 16 hours. 7. Avoid hypothermia. 8. Metabolic control: continuous monitoring of glucose and insulin infusion to treat hyperglycemia in all patients postoperatively, if glucose level are more than 11.5 mmol/l (0.1 UI/kg/h) 9. Transfer to Ward within 24 hours after surgery. Group II- Conventional protocol (Control): conventional protocol established and used for cardiac surgery in the cardiocenter of Hermanos Ameijeiras hospital

Intervention code:

Clinical Protocols

Thoracic Surgery

Perioperative Period

Perioperative Care

Intervention keyword:

Peri-operative care protocol

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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 to the questions are between 70 and 79% and, not satisfied if the affirmative answers to the questions are less than 70%). Measurement time: 30 days after surgery.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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:

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

N/A

Target sample size:

84

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Maria

Middle Name:

Oslaida

Last Name:

Aguero Martinez

Specialty:

Anesthesiology and Reanimation

Affiliation:

Hermanos Ameijeiras Hospital

Postal Address:

San Lazaro Street, between Belascoain and Marquez Gonzalez

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53 58879035

Email :

osly@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Maria

Middle Name:

Oslaida

Last Name:

Aguero Martinez

Specialty:

Anesthesiology and Reanimation

Affiliation:

Hermanos Ameijeiras Hospital

Postal Address:

San Lazaro Street, between Belascoain and Marquez Gonzalez

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53 58879035

Email :

osly@infomed.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Hermanos Ameijeiras hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

09/09/2019

Postal address of Ethic Committee :

San Lazaro Street, between Belascoain and Marquez Gonzalez. Havana. Cuba

Telephone:

+53 78761626

Correo electrónico:

invest1@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

01/12/2021

Date of available results:

04/04/2022

Date of first publication:

02/08/2022

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000304

Date of Registration in Primary Registry:

20/11/2019

Record Verification Date:

2020/10/21

Next update date:

2021/10/21

Link to the spanish version:

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