NCT03799965

Brief Summary

Investigation of the effect of Enhanced Recovery After Surgery (ERAS) program on postoperative results of patients operated for open heart surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2018

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

December 30, 2018

Last Update Submit

January 30, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • durations of stay

    compare the durations of stay in the intensive care unit and in hospital

    24 hours

  • complications

    compare the incidences of complications

    24 hours

Study Arms (2)

ERAS protocol are evaluated

ACTIVE COMPARATOR

* It is to compare the durations of stay in the intensive care unit and in hospital * It is to compare the incidences of complications of the groups

Other: ERAS (Enhanced Recovery After Surgery ) are evaluated

ERAS protocol are not evaluated

ACTIVE COMPARATOR

* It is to compare the durations of stay in the intensive care unit and in hospital * It is to compare the incidences of complications of the groups

Other: ERAS are not evaluated

Interventions

In this arm ERAS( Enhanced Recovery After Surgery) protocol will be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence.

ERAS protocol are evaluated

In this arm ERAS( Enhanced Recovery After Surgery) protocol will not be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence.

ERAS protocol are not evaluated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years old;
  • Patients undergoing elective open heart surgery (cardiopulmonarybiasis, aortic and mitral valve replacement);
  • ASA III ;
  • Patients with informed consent for the study.

You may not qualify if:

  • Patients who refuse to participate in the study;
  • Patients under emergency conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emine yurt

Kocaeli, Derince, 41400, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative CareSurgical Procedures, Operative

Central Study Contacts

Ipek Y duzyol, doctor

CONTACT

emine yurt, doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist doctor

Study Record Dates

First Submitted

December 30, 2018

First Posted

January 10, 2019

Study Start

December 1, 2017

Primary Completion

January 1, 2019

Study Completion

June 1, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations