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

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: Active, not recruiting
• Conditions: Postoperative Complications
• Intervention / Treatment: Drug: Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg; Drug: Multiple Electrolytes injection of 5 ml/kg

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: Interventional
• Enrollment (Actual): 2022
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
The incidence of post-operative complications	Modified Clavien-Dindo Classification ≥ grade I	within 30 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-induction hypotension (PIH)	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	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	The time from the end of operation to discharge from hospital	postoperatively within 30 days
the incidence of optimal recovery	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

• Sponsor: Xijing Hospital
• Collaborators: 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

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Estimated): March 28, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: December 26, 2022
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Plasma Substitutes; Blood Substitutes; Hydroxyethyl Starch Derivatives
• Other Study ID 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