Colloid Infusion for Optimal Outcomes In Non-cardiac Surgery (COIN Trial) (COIN)

June 7, 2026 updated by: Chong Lei, MD & phD, Xijing Hospital

Effect of Colloid or Crystalloid Infusion Before Induction of General Anesthesia on Postoperative Complications Within 30 Days

Hypotension is associated with postoperative complications. Preoperative fluid infusion can effectively prevent post-induction hypotension of general anesthesia. Previous studies only focused on the hemodynamics after preoperative fluid infusion. Pre-operative fluid infusion can reduce the incidence of post-operative complications by preventing post-induction hypotension. The patients who is 18 years or older and undergo elective non-cardiac surgery with general anesthsia will be enrolled. The intervention is intravenous infusion of colloids or crytalloids before induction of general anesthesia. The primary outcome is the incidence of post-operative complications within 30 days.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Post-induction hypotension occurs in 30-40% of patients undergoing surgery under general anesthesia. Perioperative hypotension is a significant independent risk factor for post-operative myocardial injury, acute kidney injury, stroke, and significantly increases 30-day mortality rate after surgery. Perioperative hypotension has been attributed to absolute or relative hypovolaemia secondary to pre-operative fasting and to the vasodilatory and negative inotropic effects of certain induction agents. Low baseline blood volume is a risk factor for post-induction hypotension. The general consensus remains that patients entering the operating room require fluids to make up for reduced pre-operative intake. Intravenous administration of 500 mL of crystalloid solution before induction of anaesthesia did not decrease the overall incidence of cardiovascular collapse during tracheal intubation of critically ill adults compared with no fluid bolus. Among patients in the intensive care unit requiring fluid challenges, intravenous crystalloid boluses of 250 ml before intubation did not reduce 90-day mortality. Preloading colloids reduced the occurrence of post-induction hypotension and vasopressor use, improved CI, and reduced SVV during the early intraoperative period. It is unknown whether pre-operative colloids infusion can reduce the incidence of post-operative complications by preventing post-induction hypotension. We will enroll patients with 18 years or older and undergoing elective surgery under general anesthsia. The participants in colloid group will receive intravenous colloids 5ml/kg before induction of anesthesia; who in crystalloid group will receive intravenous Ringer's solution 5ml/kg before induction of anesthesia. The primary outcome in this study is the incidence of post-operative complications (Clavien-Dindo) within 30 days. The secondary outcomes include the incidence of post-induction hypotension, the doses of vasopressors and inotropes intra-operatively, lengths of stay in hospital (LOS) post-operatively, optimal recovery post-operatively within 5 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2022

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years or older
  • ASA I-III
  • Undergoing elective non-cardiac surgery under general aneathesia

Exclusion Criteria:

  • Allergic to colloids
  • Severe heart diseases ( Ejection Fraction lower than 35%)
  • Presence of renal failure pre-operatively (defined as eGFR < 30 mL/min/1.73 m2 and/or patient receiving renal replacement therapy)
  • Morbid obesity (BMI > 37.5kg/m2 or > 32.5kg/m2 with metabolic diseases)
  • Presence of a coagulopathy at screening (defined as platelet count < 100 × 109/L and/or a prothrombin time < 70% and/or an activated partial thromboplastin time (aPTT) >35 s and/or fibrinogen <1 g/ L)
  • Presence of liver injury (defined as Child-Pugh C)
  • Pre-operative electrolyte disturbances with Na >160 mmol/L or <120 mmol/L
  • Patients with preoperative intracranial hypertension requiring dehydration treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: colloid group
The participants in colloid group will received intravenous Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg before the Induction of general anesthesia.
Drug: Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg
Intravenous Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg before induction of general anesthesia
Other Names:
  • colloid infusion
Active Comparator: crystalloid group
The participants in crystalloid group will received intravenous multiple electrolyte injection of 5ml/kg before the Induction of general anesthesia.
Drug: Multiple Electrolytes injection of 5 ml/kg
Intravenous Multiple Electrolytes injection of 5ml/kg before induction of general anesthesia
Other Names:
  • Crystalloid infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence of post-operative complications
Time Frame: within 30 days after operation
Modified Clavien-Dindo Classification ≥ grade I
within 30 days after operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-induction hypotension (PIH)
Time Frame: during procedure ( the time from induction of anesthesia to incision)
MAP < 65mmHg or 20% lower than the baseline from the time of anesthsia induction to incison
during procedure ( the time from induction of anesthesia to incision)
The doses of vasopressors and inotropes
Time Frame: intra-operatively，the time from induction of anesthesia to discharge from operating room
including epinephrine, norepinephrine, dopamine.
intra-operatively，the time from induction of anesthesia to discharge from operating room
Lengths of stay in hospital (LOS) post-operatively
Time Frame: postoperatively within 30 days
The time from the end of operation to discharge from hospital
postoperatively within 30 days
the incidence of optimal recovery
Time Frame: post-operatively within 5 days
Defined as discharge within 5 days of surgery with no major complications (Clavien-Dindo ≥ III), no infections of incisions, no re-admissions to hospital, and no deaths post-operatively
post-operatively within 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Affiliated Hospital Of Guizhou Medical University
First Affiliated Hospital of Chongqing Medical University
Shenzhen University General Hospital
Ningbo No.2 Hospital
The Second Affiliated Hospital of Dalian Medical University
Yan'an University Affiliated Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20222318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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