Postoperative ComplicationsBIA-HYD-CRCNCT07823530
Bioelectrical Response to Preoperative Hydration in Colorectal Surgery
A study testing Ionolyte Balanced Isotonic Crystalloid in people with Postoperative Complications, run by University Hospital of Split at 1 site in Croatia.
Trial summary
This single-center study will evaluate whether short-term changes in bioelectrical impedance measurements after a standardized preoperative intravenous fluid infusion can help predict complications following elective colon or rectal surgery. The prospective group will include 120 consecutive adults. 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?
- Ionolyte Balanced Isotonic Crystalloid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Oct 2026to 30 Sep 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older
- Scheduled for elective colon or rectal resection at University Hospital of Split
- Written informed consent before research-specific procedures
- Able to stand safely and complete both BIA measurements
- Preoperative eGFR at least 60 mL/min/1.73 m²
- Clinically eligible for the protocol fluid volume
Who cannot join
- Emergency surgery
- eGFR below 60 mL/min/1.73 m² or oliguria
- Heart failure or clinically significant cardiac disease making fluid loading inappropriate
- Edema, pulmonary congestion, or clinically significant ascites
- Active implantable electrical device
- Limb amputation, inability to undergo standardized standing BIA, or unsafe standing
Show all 10Show fewer
- Clinically significant electrolyte abnormality
- Pregnancy
- Contraindication to Ionolyte or any clinician safety concern
- Inability to provide valid informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
University Hospital of Split, Department of Surgery
Split, Split-Dalmatia County, 21000
Petra Nizeteo, MD, +38521551457, petra.nizeteo@kbsplit.hr
About this study
Official title: Bioelectrical Response to Standardized Preoperative Hydration and Its Association With Short- and Long-Term Outcomes After Elective Colon and Rectal Resections: An Ambispective Controlled Cohort Study
This single-center study will evaluate whether short-term changes in bioelectrical impedance measurements after a standardized preoperative intravenous fluid infusion can help predict complications following elective colon or rectal surgery. The prospective group will include 120 consecutive adults. After emptying the bladder, participants will be weighed and assessed barefoot on a standing multifrequency bioelectrical impedance device. They will then receive Ionolyte, a balanced isotonic crystalloid, at 15 mL/kg based on the lower of actual and ideal body weight, up to 1,000 mL, over exactly 40 minutes. Participants will empty the bladder again and undergo repeat measurement 60 minutes after infusion start. The main predictor is the continuous change in phase angle, and the main outcome is at least one Clavien-Dindo grade II-V complication within 30 days. A supportive analysis will compare clinical outcomes with 240 consecutive historical controls using existing hospital records. The historical controls do not receive the study procedure and are not included in the prospective enrollment.
Read the detailed description
The prospective component is protocol-assigned, non-randomized, open-label, and single-group. Dosing weight is the lower of actual body weight measured at T0 and ideal body weight calculated from sex and height using the Robinson equations. An eGFR of at least 60 mL/min/1.73 m² is an eligibility criterion and is not used to calculate fluid volume.
From infusion start through T60, food, drink, and other intravenous fluids are withheld unless clinically required. Routine walking to the toilet and standing scale is permitted. Only T0 and T60 research BIA measurements are performed. Clinical care takes priority over the protocol, and symptoms or clinician concern require stopping the infusion and performing a medical assessment.
Short-term outcomes are assessed through 90 postoperative days. Long-term outcomes include overall survival and, in participants with malignant disease, recurrence-free survival for up to five years.
The complete ambispective research program also includes 240 consecutive eligible patients operated on immediately before implementation of the prospective protocol. Their data are obtained retrospectively from existing University Hospital of Split records without contact or additional procedures, under the approved waiver of consent. This historical comparison is not a prospectively assigned ClinicalTrials.gov arm and is not included in the anticipated enrollment of 120.
- Conditions
- Postoperative Complications
- Being tested
- Ionolyte Balanced Isotonic Crystalloid
- Keywords
- Colorectal Surgery, Bioelectrical Impedance Analysis, Phase Angle, Extracellular Water, Intracellular Water, Body Composition, Preoperative Hydration, Balanced Isotonic Crystalloid, Perioperative Fluid Therapy, Clavien-Dindo Classification
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ionolyte Balanced Isotonic CrystalloidDrug
Also called Balanced Isotonic Crystalloid
Ionolyte is administered intravenously at 15 mL/kg dosing weight, up to a maximum of 1,000 mL, over exactly 40 minutes. Dosing weight is the lower of actual body weight measured at T0 and ideal body weight calculated from sex and height using the Robinson equations. The infusion rate in mL/h equals the total volume multiplied by 1.5.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Ionolyte Hydration and Serial BIA | Experimental | Prospective participants undergo standardized BIA and weighing at T0 after bladder emptying, protocol-defined Ionolyte infusion over exactly 40 minutes, repeat bladder emptying, and BIA and weighing at T60, followed by usual elective colon or rectal resection and outcome follow-up. Receives: Drug: Ionolyte Balanced Isotonic Crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With at Least One Clavien-Dindo Grade II-V Postoperative Complication
Number and proportion of participants experiencing at least one postoperative complication graded II, III, IV, or V according to the Clavien-Dindo classification.
Measured: From surgery through postoperative day 30
Secondary outcomes (19)
Change in Phase Angle
Whole-body/software-reported phase angle at T60 minus T0, analyzed continuously.
Measured: T0 to 60 minutes after infusion start
Change in Extracellular Water
Extracellular water at T60 minus extracellular water at T0, measured in kilograms and analyzed continuously.
Measured: T0 to 60 minutes after infusion start
Major Postoperative Complications
Participants with at least one Clavien-Dindo grade III-V complication.
Measured: Through postoperative day 30
Comprehensive Complication Index
Cumulative postoperative morbidity on the 0-100 CCI scale; higher scores indicate greater morbidity.
Measured: Through postoperative day 30
Surgical-Site Infection
Participants meeting the protocol-defined surgical-site infection criteria.
Measured: Through postoperative day 30
Anastomotic Leakage
Participants with clinically and/or radiologically diagnosed anastomotic leakage according to the protocol definition.
Measured: Through postoperative day 30
Number of Participants With Acute Kidney Injury
Participants meeting KDIGO acute kidney injury criteria based on available creatinine and/or valid routine urine-output data.
Measured: From surgery through postoperative day 30
Length of Hospital Stay
Number of days from the colon or rectal resection to discharge from the hospitalization during which the resection was performed.
Measured: From colon or rectal resection through discharge from the hospitalization during which the resection was performed, up to 90 days after surgery
Number of Participants With an Unplanned Reoperation
Participants undergoing an unplanned reoperation.
Measured: Through postoperative day 30
Number of Participants With Hospital Readmission
Participants readmitted after discharge.
Measured: Through postoperative day 30
All-Cause Mortality
All-cause mortality reported separately at 30 and 90 days.
Measured: Postoperative days 30 and 90
Overall Survival
Time from surgery to death from any cause; living participants are censored at last known follow-up.
Measured: Up to 5 years after surgery
Recurrence-Free Survival
For malignant disease with available follow-up, time from surgery to documented recurrence or death according to the statistical analysis plan definition.
Measured: Up to 5 years after surgery
Change in Intracellular Water
Intracellular water at T60 minus intracellular water at T0, measured in kilograms and analyzed continuously.
Measured: T0 to 60 minutes after infusion start
Change in Total Body Water
Total body water at T60 minus total body water at T0, measured in kilograms and analyzed continuously.
Measured: T0 to 60 minutes after infusion start
Change in Extracellular Water to Total Body Water Ratio
The device-reported ECW/TBW ratio at T60 minus the ratio at T0, analyzed continuously.
Measured: T0 to 60 minutes after infusion start
Change in Whole-Body Resistance at 50 kHz
Whole-body resistance at 50 kHz at T60 minus resistance at T0, measured in ohms and analyzed continuously.
Measured: T0 to 60 minutes after infusion start
Change in Whole-Body Reactance at 50 kHz
Whole-body reactance at 50 kHz at T60 minus reactance at T0, measured in ohms and analyzed continuously.
Measured: T0 to 60 minutes after infusion start
Change in Body Weight
Body weight at T60 minus body weight at T0, measured in kilograms and analyzed continuously.
Measured: T0 to 60 minutes after infusion start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Sep 2033 (estimated)
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same standardized preoperative Ionolyte infusion and undergo BIA measurements at T0 and T60; there is no concurrent control arm.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ognjen Barčot, MD, PhD, University Hospital of Split
- Investigators
- Petra Nizeteo, MD, Principal investigator, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823530
- Sponsor's protocol ID
- BIA-HYDRATE-CRC
- Other IDs
- 2181-147/01-06/LJ.Z.-26-02, 2181-147/01-06/LJ.Z.-26-04
- Acronym
- BIA-HYD-CRC
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. The protocol, statistical analysis plan, data-management description, and aggregate results will be shared. Any future controlled sharing would require separate institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioelectrical Response to Standardized Preoperative Hydration and Its Association With Short- and Long-Term Outcomes After Elective Colon and Rectal Resections: An Ambispective Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT07823530
- Acronym / sponsor ID
- BIA-HYD-CRC / BIA-HYDRATE-CRC
- Conditions
- Postoperative Complications
- Keywords
- Colorectal Surgery, Bioelectrical Impedance Analysis, Phase Angle, Extracellular Water, Intracellular Water, Body Composition, Preoperative Hydration, Balanced Isotonic Crystalloid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 16 Sep 2026 (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.
This single-center study will evaluate whether short-term changes in bioelectrical impedance measurements after a standardized preoperative intravenous fluid infusion can help predict complications following elective colon or rectal surgery. The prospective group will include 120 consecutive adults. After emptying the bladder, participants will be weighed and assessed barefoot on a standing multifrequency bioelectrical impedance device. They will then receive Ionolyte, a balanced isotonic crystalloid, at 15 mL/kg based on the lower of actual and ideal body weight, up to 1,000 mL, over exactly 40 minutes. Participants will empty the bladder again and undergo repeat measurement 60 minutes after infusion start. The main predictor is the continuous change in phase angle, and the main outcome is at least one Clavien-Dindo grade II-V complication within 30 days. A supportive analysis will compare clinical outcomes with 240 consecutive historical controls using existing hospital records. The historical controls do not receive the study procedure and are not included in the prospective enrollment.
Detailed description
The prospective component is protocol-assigned, non-randomized, open-label, and single-group. Dosing weight is the lower of actual body weight measured at T0 and ideal body weight calculated from sex and height using the Robinson equations. An eGFR of at least 60 mL/min/1.73 m² is an eligibility criterion and is not used to calculate fluid volume.
From infusion start through T60, food, drink, and other intravenous fluids are withheld unless clinically required. Routine walking to the toilet and standing scale is permitted. Only T0 and T60 research BIA measurements are performed. Clinical care takes priority over the protocol, and symptoms or clinician concern require stopping the infusion and performing a medical assessment.
Short-term outcomes are assessed through 90 postoperative days. Long-term outcomes include overall survival and, in participants with malignant disease, recurrence-free survival for up to five years.
The complete ambispective research program also includes 240 consecutive eligible patients operated on immediately before implementation of the prospective protocol. Their data are obtained retrospectively from existing University Hospital of Split records without contact or additional procedures, under the approved waiver of consent. This historical comparison is not a prospectively assigned ClinicalTrials.gov arm and is not included in the anticipated enrollment of 120.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same standardized preoperative Ionolyte infusion and undergo BIA measurements at T0 and T60; there is no concurrent control arm.
| Arm | Type | Receives |
|---|---|---|
| Standardized Ionolyte Hydration and Serial BIA | Experimental | Drug: Ionolyte Balanced Isotonic CrystalloidProspective participants undergo standardized BIA and weighing at T0 after bladder emptying, protocol-defined Ionolyte infusion over exactly 40 minutes, repeat bladder emptying, and BIA and weighing at T60, followed by usual elective colon or rectal resection and outcome follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Scheduled for elective colon or rectal resection at University Hospital of Split
- Written informed consent before research-specific procedures
- Able to stand safely and complete both BIA measurements
- Preoperative eGFR at least 60 mL/min/1.73 m²
Key exclusion criteria (10 listed)
- Emergency surgery
- eGFR below 60 mL/min/1.73 m² or oliguria
- Heart failure or clinically significant cardiac disease making fluid loading inappropriate
- Edema, pulmonary congestion, or clinically significant ascites
- Active implantable electrical device
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 |
|---|---|---|
| Ionolyte Balanced Isotonic CrystalloidAlso: Balanced Isotonic CrystalloidIonolyte is administered intravenously at 15 mL/kg dosing weight, up to a maximum of 1,000 mL, over exactly 40 minutes. Dosing weight is the lower of actual body weight measured at T0 and ideal body weight calculated from sex and height using the Robinson equations. The infusion rate in mL/h equals the total volume multiplied by 1.5. | Drug | Standardized Ionolyte Hydration and Serial BIA |
Primary outcome
Participants With at Least One Clavien-Dindo Grade II-V Postoperative Complication
Time frame: From surgery through postoperative day 30
Number and proportion of participants experiencing at least one postoperative complication graded II, III, IV, or V according to the Clavien-Dindo classification.
19 secondary outcomes
Change in Phase Angle
Time frame: T0 to 60 minutes after infusion start
Change in Extracellular Water
Time frame: T0 to 60 minutes after infusion start
Major Postoperative Complications
Time frame: Through postoperative day 30
Comprehensive Complication Index
Time frame: Through postoperative day 30
Surgical-Site Infection
Time frame: Through postoperative day 30
Anastomotic Leakage
Time frame: Through postoperative day 30
Number of Participants With Acute Kidney Injury
Time frame: From surgery through postoperative day 30
Length of Hospital Stay
Time frame: From colon or rectal resection through discharge from the hospitalization during which the resection was performed, up to 90 days after surgery
Number of Participants With an Unplanned Reoperation
Time frame: Through postoperative day 30
Number of Participants With Hospital Readmission
Time frame: Through postoperative day 30
All-Cause Mortality
Time frame: Postoperative days 30 and 90
Overall Survival
Time frame: Up to 5 years after surgery
Recurrence-Free Survival
Time frame: Up to 5 years after surgery
Change in Intracellular Water
Time frame: T0 to 60 minutes after infusion start
Change in Total Body Water
Time frame: T0 to 60 minutes after infusion start
Change in Extracellular Water to Total Body Water Ratio
Time frame: T0 to 60 minutes after infusion start
Change in Whole-Body Resistance at 50 kHz
Time frame: T0 to 60 minutes after infusion start
Change in Whole-Body Reactance at 50 kHz
Time frame: T0 to 60 minutes after infusion start
Change in Body Weight
Time frame: T0 to 60 minutes after infusion start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. The protocol, statistical analysis plan, data-management description, and aggregate results will be shared. Any future controlled sharing would require separate institutional and ethical approval.
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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.
Petra Nizeteo, MD principal investigator
University Hospital of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ionolyte Balanced Isotonic Crystalloid in people with Postoperative Complications, run by University Hospital of Split at 1 site in Croatia.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 16 Sep 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 Croatia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ognjen Barcot, MD, PhD (+38521556691, ognjen.barcot@kbsplit.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With at Least One Clavien-Dindo Grade II-V Postoperative Complication (time frame: From surgery through postoperative day 30). 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 16 Sep 2026.