Postoperative ComplicationsCOINNCT05728645
Colloid Infusion for Optimal Outcomes In Non-cardiac Surgery (COIN Trial)
A study testing Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg and Multiple Electrolytes injection of 5 ml/kg in people with Postoperative Complications, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg and Multiple Electrolytes injection of 5 ml/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,022 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- ASA I-III
- Undergoing elective non-cardiac surgery under general aneathesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Complications
- Being tested
- Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg, Multiple Electrolytes injection of 5 ml/kg
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kgDrug
Also called colloid infusion
Intravenous Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg before induction of general anesthesia
Multiple Electrolytes injection of 5 ml/kgDrug
Also called Crystalloid infusion
Intravenous Multiple Electrolytes injection of 5ml/kg before induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Multiple Electrolytes injection of 5 ml/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of post-operative complications
Modified Clavien-Dindo Classification ≥ grade I
Measured: within 30 days after operation
Secondary outcomes (4)
Post-induction hypotension (PIH)
MAP < 65mmHg or 20% lower than the baseline from the time of anesthsia induction to incison
Measured: during procedure ( the time from induction of anesthesia to incision)
The doses of vasopressors and inotropes
including epinephrine, norepinephrine, dopamine.
Measured: 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
Measured: 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
Measured: post-operatively within 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start12 Jul 2023
- Primary completion28 Mar 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,022 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No.2 Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Chongqing Medical University, The Second Affiliated Hospital of Dalian Medical University, Yan'an University Affiliated Hospital, Shenzhen University General Hospital
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728645
- Sponsor's protocol ID
- KY20222318
- Acronym
- COIN
- Status last verified
- Jun 2026
- First submitted
- 26 Dec 2022
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colloid or Crystalloid Infusion Before Induction of General Anesthesia on Postoperative Complications Within 30 Days
- ClinicalTrials.gov ID
- NCT05728645
- Acronym / sponsor ID
- COIN / KY20222318
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,022 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Ningbo No.2 Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Chongqing Medical University, The Second Affiliated Hospital of Dalian Medical University, Yan'an University Affiliated Hospital, Shenzhen University General Hospital
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colloid group | Experimental | Drug: Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kgThe participants in colloid group will received intravenous Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg before the Induction of general anesthesia. |
| crystalloid group | Active comparator | Drug: Multiple Electrolytes injection of 5 ml/kgThe participants in crystalloid group will received intravenous multiple electrolyte injection of 5ml/kg before the Induction of general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- ASA I-III
- Undergoing elective non-cardiac surgery under general aneathesia
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kgAlso: colloid infusionIntravenous Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg before induction of general anesthesia | Drug | colloid group |
| Multiple Electrolytes injection of 5 ml/kgAlso: Crystalloid infusionIntravenous Multiple Electrolytes injection of 5ml/kg before induction of general anesthesia | Drug | crystalloid group |
Primary outcome
The incidence of post-operative complications
Time frame: within 30 days after operation
Modified Clavien-Dindo Classification ≥ grade I
4 secondary outcomes
Post-induction hypotension (PIH)
Time frame: 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
Lengths of stay in hospital (LOS) post-operatively
Time frame: postoperatively within 30 days
the incidence of optimal recovery
Time frame: post-operatively within 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg and Multiple Electrolytes injection of 5 ml/kg in people with Postoperative Complications, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of post-operative complications (time frame: within 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.