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NCT Number: NCT05728645

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: colloid infusion

Multiple Electrolytes injection of 5 ml/kg

Drug

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

Other names: Crystalloid infusion

Primary outcomes

  1. The incidence of post-operative complications

    Time frame: within 30 days after operation

    Modified Clavien-Dindo Classification ≥ grade I

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: COIN

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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