Goal-oriented Fluid TherapyKEROSNCT01874730

KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

A study testing Combined epidural-general anesthesia (CEGA) and Volulyte® (6% HES 130/0.4 in balanced solution) in people with Goal-oriented Fluid Therapy and Colorectal Surgery, run by Duke University at 3 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 45 to 80 years
Conditions the study is for: Goal-oriented Fluid Therapy, Colorectal Surgery
What is being tested?: Combined epidural-general anesthesia (CEGA) and Volulyte® (6% HES 130/0.4 in balanced solution)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 3 sitesSouth Korea
Study dates: Jul 2013to Jun 2015
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 45 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Elective, open colorectal surgery including sigmoid resections, i.e. with an upper rectal anastomosis and with or without planned stoma. If the planned surgery is a combined procedure, the associated procedure should not add more than 1 hour to the surgery time of the primary colorectal surgical procedure alone.
Both genders; age ≥ 45 years and ≤ 80 years.
ASA Grades I-III
Voluntary participation and signing the informed consent form

Who cannot join

Fluid overload (hyperhydration), especially in cases of pulmonary edema and congestive heart failure, or patients with severe cardiovascular disorders (New York Heart Association, NYHA III-IV)
Patients with significant cardiac arrhythmias or depending on pacemaker
Patients with impaired liver and/or kidney functions (ALT more than 2 times the normal upper limit and/or Serum Creatinine (SCr) more than 2 times the normal upper limit)
Renal failure with oliguria or anuria not related to hypovolemia
Patients receiving dialysis treatment
Patients with non-resectable malignancies

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Patients who are non-cooperative or non-communicable
Patients with significant preoperative coagulation abnormalities
Patients receiving treatment with opioids for significant chronic pain
Patients in need of organ transplantation
Intracranial hemorrhage
Severe hypernatremia (Na+ > 155 mmol/l) or severe hyperchloremia (Cl- > 125 mmol/l)
Known hypersensitivity to hydroxyethyl starches
Participation in a clinical trial of an investigational drug or device within 30 days before study screening visit or is scheduled to receive an investigational product while participating in this study
Patients with evidenced bowel obstruction symptoms.
Contraindication to epidural anesthesia
Known pregnancy and lactation

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

Samsung Medical Center
Gangnam-Gu, Seoul, 135-710
Yonsei University College of Medicine
Seodaemun-gu, Seoul
Asan Medical Center
Songpa-gu, Seoul, 138-736

Other trials in South Korea

About this study

This is a multi-centre study to take place in approximately 3 centers in Seoul, South Korea. The study will be carried out as a prospective, randomized, controlled, multicenter, clinical trial in patients undergoing colorectal surgery. The purpose of this study is to determine if an enhanced recovery strategy paying close attention to the type and amount of fluid given during the surgery with proper monitoring combined with a comprehensive perioperative pain management will have a better post-operative outcome compared to institutional standard of care (SOC), in patients undergoing surgery of the colon. One of the fluids used, Volulyte®, is an intravenous solution used to treat low blood volume. The Volulyte® solution being used in the study and the monitor used are approved by the Korean Food and Drug Administration

Conditions: Goal-oriented Fluid Therapy, Colorectal Surgery
Being tested: Combined epidural-general anesthesia (CEGA), Volulyte® (6% HES 130/0.4 in balanced solution), Patient-Controlled Epidural Analgesia (PCEA)
Keywords: colorectal surgery, fluid therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combined epidural-general anesthesia (CEGA)Other
Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.
Volulyte® (6% HES 130/0.4 in balanced solution)Drug
For the SOC Group: Intraoperative fluid management includes Volulyte® (6% HES 130/0.4 in balanced solution) as the only colloid solution to be used, the daily dosage of Volulyte® is restricted to 50 ml/kg.
For the ERS Group:
GDFT regimen will be utilized using Volulyte® (6% HES 130/0.4 in balanced solution) during surgery. The daily dosage of Volulyte® is restricted to 50 ml/kg.
Patient-Controlled Epidural Analgesia (PCEA)Other
For the ERS Group, patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.

Study groups in NCT01874730
Study group	Role	What they receive
Standard of Care (SOC)	Other	Intraoperative fluid management includes Volulyte® (6% hydroxyethyl starch {HES} 130/0.4 in balanced solution) as the only colloid solution to be used, the daily dosage of Volulyte® is restricted to 50 ml/kg. Intraoperative anesthesia and postoperative analgesia will follow the established practice of the individual institution. Receives: Drug: Volulyte® (6% HES 130/0.4 in balanced solution)
Enhanced Recovery Strategy (ERS) group	Active comparator	GDFT regimen using Volulyte® (6% HES 130/0.4 in balanced solution) during surgery. The daily dosage of Volulyte® is restricted to 50 ml/kg. Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen. Receives: Other: Combined epidural-general anesthesia (CEGA); Drug: Volulyte® (6% HES 130/0.4 in balanced solution); Other: Patient-Controlled Epidural Analgesia (PCEA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Outcome
Postoperative outcome is defined as the number of patients who develop at least one postoperative complication during their hospital stay
Measured: From Day 1 after surgery and duration of hospital stay (approximately 6 days after surgery)

Secondary outcomes (5)

Postoperative outcome for each patient at postoperative day (POD) 30
Postoperative outcome for each patient at postoperative day (POD) 30 is defined as whether the patient encountered at least one postoperative complication up to POD 30
Measured: From Hospital Discharge (approximately 6 days after surgery), up to 4 weeks after day of surgery
Number of postoperative complications per group
Number of postoperative complications per group evaluated postoperatively from date of surgery, each hospital day, (post-operative days 1 through 5), at discharge from the hospital until 30 days from day of surgery.
Measured: Participants will be followed for the duration of hospital stay (approximately 6 days after surgery), and until 4 weeks from day of surgery
Time to "clinically fit for discharge from hospital"
Time to "clinically fit for discharge from hospital" when defined discharge criteria are met (evaluation starts from POD 4 at 10 am each day till discharge).
Measured: From 4 days after surgery to Hospital discharge (approximately 6 days after surgery)
Change in Postoperative pain
Postoperative pain at 1h, 2 h, 6 h, 24 h, and post-operative days 1 through 5, and at discharge (evaluated with a verbal rating scale (VRS), 0 = no pain, 10 = worst possible pain) until discharge. Pain assessment is performed at rest and during activity (cough).
Measured: 1h, 2 h, 6 h, 24 h post-surgery, and post-operative days 1 through 5, and at discharge
change in incidence of nausea and vomiting
The incidence of nausea and vomiting at 1h, 2 h, 24 h, and post-operative days 2 through 5, and at discharge from the hospital.
Measured: 1h, 2 h, 24 h post-surgery, and post-operative days 2 through 5, and at discharge from the hospital (approximately 6 days after surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Jun 2015

First posted11 Jun 2013 (estimated)
Study startJul 2013
Primary completionJun 2015
Study completionJun 2015

Why it stopped: Very slow accrual because sites have few open colorectal surgery

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Goal-oriented Fluid TherapyStudies of the same condition, open and under way.
More trials run by Duke UniversityThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01874730
Sponsor's protocol ID: Pro00038567
Acronym: KEROS
Status last verified: Aug 2015
First submitted: 4 Jun 2013
Last updated: 7 Aug 2015
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: KOREAN Enhanced RecOvery Strategy for Colorectal Surgery
ClinicalTrials.gov ID: NCT01874730
Acronym / sponsor ID: KEROS / Pro00038567
Conditions: Goal-oriented Fluid Therapy, Colorectal Surgery
Keywords: colorectal surgery, fluid therapy
Study type: Interventional
Recruitment status: TerminatedReason stopped: Very slow accrual because sites have few open colorectal surgery
Enrolment: 101 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Jul 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 11 Jun 2013 (estimated)
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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard of Care (SOC)	Other	Drug: Volulyte® (6% HES 130/0.4 in balanced solution)Intraoperative fluid management includes Volulyte® (6% hydroxyethyl starch {HES} 130/0.4 in balanced solution) as the only colloid solution to be used, the daily dosage of Volulyte® is restricted to 50 ml/kg. Intraoperative anesthesia and postoperative analgesia will follow the established practice of the individual institution.
Enhanced Recovery Strategy (ERS) group	Active comparator	Other: Combined epidural-general anesthesia (CEGA), Drug: Volulyte® (6% HES 130/0.4 in balanced solution), Other: Patient-Controlled Epidural Analgesia (PCEA)GDFT regimen using Volulyte® (6% HES 130/0.4 in balanced solution) during surgery. The daily dosage of Volulyte® is restricted to 50 ml/kg. Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.

Who may qualify

Ages: 45 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Elective, open colorectal surgery including sigmoid resections, i.e. with an upper rectal anastomosis and with or without planned stoma. If the planned surgery is a combined procedure, the associated procedure should not add more than 1 hour to the surgery time of the primary colorectal surgical procedure alone.
Both genders; age ≥ 45 years and ≤ 80 years.
ASA Grades I-III
Voluntary participation and signing the informed consent form

Key exclusion criteria (17 listed)

Fluid overload (hyperhydration), especially in cases of pulmonary edema and congestive heart failure, or patients with severe cardiovascular disorders (New York Heart Association, NYHA III-IV)
Patients with significant cardiac arrhythmias or depending on pacemaker
Patients with impaired liver and/or kidney functions (ALT more than 2 times the normal upper limit and/or Serum Creatinine (SCr) more than 2 times the normal upper limit)
Renal failure with oliguria or anuria not related to hypovolemia
Patients receiving dialysis treatment

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
Combined epidural-general anesthesia (CEGA)Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.	Other	Enhanced Recovery Strategy (ERS) group
Volulyte® (6% HES 130/0.4 in balanced solution)For the SOC Group: Intraoperative fluid management includes Volulyte® (6% HES 130/0.4 in balanced solution) as the only colloid solution to be used, the daily dosage of Volulyte® is restricted to 50 ml/kg. For the ERS Group: GDFT regimen will be utilized using Volulyte® (6% HES 130/0.4 in balanced solution) during surgery. The daily dosage of Volulyte® is restricted to 50 ml/kg.	Drug	Enhanced Recovery Strategy (ERS) group, Standard of Care (SOC)
Patient-Controlled Epidural Analgesia (PCEA)For the ERS Group, patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.	Other	Enhanced Recovery Strategy (ERS) group

Primary outcome

Postoperative Outcome
Time frame: From Day 1 after surgery and duration of hospital stay (approximately 6 days after surgery)
Postoperative outcome is defined as the number of patients who develop at least one postoperative complication during their hospital stay

5 secondary outcomes

Postoperative outcome for each patient at postoperative day (POD) 30
Time frame: From Hospital Discharge (approximately 6 days after surgery), up to 4 weeks after day of surgery
Number of postoperative complications per group
Time frame: Participants will be followed for the duration of hospital stay (approximately 6 days after surgery), and until 4 weeks from day of surgery
Time to "clinically fit for discharge from hospital"
Time frame: From 4 days after surgery to Hospital discharge (approximately 6 days after surgery)
Change in Postoperative pain
Time frame: 1h, 2 h, 6 h, 24 h post-surgery, and post-operative days 1 through 5, and at discharge
change in incidence of nausea and vomiting
Time frame: 1h, 2 h, 24 h post-surgery, and post-operative days 2 through 5, and at discharge from the hospital (approximately 6 days after surgery)

Results and safety

The study was stopped early (reason given: Very slow accrual because sites have few open colorectal surgery). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.

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.

Tong J Gan, MD, MHS principal investigator

Duke University

Yang-Sik Shin, MD principal investigator

Shinchon Severance Hospital

Duk-Kyung Kim, MD PhD principal investigator

Samsung Medical Center

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 17 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: stopped early, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. 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 was stopped early (reason given: Very slow accrual because sites have few open colorectal surgery). Results are not available in the source record.

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?

Postoperative Outcome (time frame: From Day 1 after surgery and duration of hospital stay (approximately 6 days after surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01874730.

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 7 Aug 2015.