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

NCT05728645 | Active Not Recruiting DMC

• 1 other identifier: KY20222318
• Study Type: interventional
• Target: 2,022
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• The incidence of post-operative complications

  Modified Clavien-Dindo Classification ≥ grade I

  within 30 days after operation

Secondary Outcomes (4)

• Post-induction hypotension (PIH)

  during procedure ( the time from induction of anesthesia to incision)

• The doses of vasopressors and inotropes

  intra-operatively，the time from induction of anesthesia to discharge from operating room

• Lengths of stay in hospital (LOS) post-operatively

  postoperatively within 30 days

• the incidence of optimal recovery

  post-operatively within 5 days

Study Arms (2)

colloid group

EXPERIMENTAL

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

crystalloid group

ACTIVE COMPARATOR

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

Interventions

Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg DRUG

Intravenous Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg before induction of general anesthesia

Also known as: colloid infusion

colloid group

Multiple Electrolytes injection of 5 ml/kg DRUG

Intravenous Multiple Electrolytes injection of 5ml/kg before induction of general anesthesia

Also known as: Crystalloid infusion

crystalloid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead
• Ningbo No.2 Hospital: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Yan'an University Affiliated Hospital: collaborator
• Shenzhen University General Hospital: collaborator

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Hydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD &amp;amp; PhD

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: February 15, 2023
• Study Start: July 12, 2023
• Primary Completion: March 28, 2025
• Study Completion: August 31, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

CN (1)