Esophageal NeoplasmNCT02033213
Volume Restriction in Esophageal Carcinoma Surgery: Randomized Clinical Trial
A study testing Restrictive group and Liberal group in people with Esophageal Neoplasm, run by Klinički Bolnički Centar Zagreb at 1 site in Croatia.
Trial summary
An exploratory single-centre randomized clinical trial was performed in order to investigate whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary gas exchange and tissue perfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasm
- What is being tested?
- Restrictive group and Liberal group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCroatia
- Study dates
- Jun 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- esophageal carcinoma
- Lewis Tanner procedure (median laparotomy and right thoracotomy)
Who cannot join
- younger than 18 years
- severe lung disease
- chronic renal insufficiency
- a physical status classification > III on the American Society of Anesthesiologists (ASA) scale
- impossible to perform epidural catheter placement
- thoraco-phreno-laparotomy
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Department of Thoracic surgery "Jordanovac" University Hospital Centre Zagreb
Zagreb, City of Zagreb, 10 000
About this study
Official title: Intraoperative Volume Restriction in Esophageal Carcinoma Surgery: an Exploratory Randomized Clinical Trial
An exploratory single-centre randomized clinical trial was performed in order to investigate whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary gas exchange and tissue perfusion.
Read the detailed description
A convenience sample of 16 patients admitted to the Department of Thoracic surgery University Hospital Centre Zagreb and scheduled for esophageal carcinoma surgery were enrolled prospectively in the study between June 2011 and August 2012.
Patients were randomly allocated into two groups, one of which received ≤ 8ml/kg/h of intraoperative fluid ("restrictive group") and another that received > 8 ml/kg/h of fluid ("liberal group").
Patients were excluded if they were younger than 18 years; if they had severe lung disease, chronic renal insufficiency, or a physical status classification > III on the American Society of Anesthesiologists (ASA) scale; or if it was impossible to perform epidural catheter placement or thoraco-phreno-laparotomy.
All patients underwent esophagectomy carried out according to the Lewis-Tanner approach.
Data on arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the ratio PaO2/FiO2 were collected 10 min after anesthesia was induced and again 6 h after surgery. Data on the metabolic markers creatinine and lactate were collected 10 min after anesthesia induction and 6 h after surgery.
ANOVA tests were performed to determine significant differences in mean values between study groups. Independent-sample t-tests were used to test differences in mean values between the restrictive and liberal groups for each of the two sets of measurements separately (10 minutes after anesthesia induction and 6 hr after surgery). P < 0.05 was considered significant.
- Conditions
- Esophageal Neoplasm
- Being tested
- Restrictive group, Liberal group
- Keywords
- intraoperative, fluid management, esophageal carcinoma, surgery, gas exchange, tissue perfusion
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive groupOther
Also called Intraoperative restrictive fluid management
A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.
Liberal groupOther
Also called Intraoperative liberal fluid management
A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive group | Active comparator | Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells. Receives: Other: Restrictive group |
| Liberal group | Active comparator | Patients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells. Receives: Other: Liberal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)
At the given time point, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the PaO2/FiO2 ratio will be measured. The results of Pa02/FiO2 ratio will be compared between two groups for each time point separately.
Measured: 10 minutes, 6 hours
Creatinine Values During and After Esophageal Carcinoma Surgery
At the given time points, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, creatinine blood levels will be measured. The results will be compared between two groups for each time point separately.
Measured: 10 minutes, 6 hours
Lactate Values During and After Esophageal Carcinoma Surgery
At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared between two groups for each time point separately.
Measured: 10 minutes, 6 hours
Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.
At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared inside the same group (liberal or restrictive).
Measured: 10 minutes, 6 hours
Secondary outcomes (2)
Duration of Surgery
Total time of Lewis-Tanner procedure will be measured and compared between two groups.
Measured: End of surgery.
Total Volume of Administered Intraoperative Fluid
Total volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups.
Measured: End of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJun 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinički Bolnički Centar Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Karaman Ilić, Klinički Bolnički Centar Zagreb
- Investigators
- Maja Karaman Ilić, MD PhD, Principal investigator, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033213
- Sponsor's protocol ID
- JORTK3
- Status last verified
- Apr 2014
- First submitted
- 7 Jan 2014
- Last updated
- 26 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Karaman Ilic M, Madzarac G, Kogler J, Stancic-Rokotov D, Hodoba N. Intraoperative volume restriction in esophageal cancer surgery: an exploratory randomized clinical trial. Croat Med J. 2015 Jun;56(3):290-6. doi: 10.3325/cmj.2015.56.290.
PubMed 26088854
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Volume Restriction in Esophageal Carcinoma Surgery: an Exploratory Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02033213
- Acronym / sponsor ID
- JORTK3
- Conditions
- Esophageal Neoplasm
- Keywords
- intraoperative, fluid management, esophageal carcinoma, surgery, gas exchange, tissue perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Klinički Bolnički Centar ZagrebUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Posted 26 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An exploratory single-centre randomized clinical trial was performed in order to investigate whether the fluid volume administered during esophageal carcinoma surgery affects pulmonary gas exchange and tissue perfusion.
Detailed description
A convenience sample of 16 patients admitted to the Department of Thoracic surgery University Hospital Centre Zagreb and scheduled for esophageal carcinoma surgery were enrolled prospectively in the study between June 2011 and August 2012.
Patients were randomly allocated into two groups, one of which received ≤ 8ml/kg/h of intraoperative fluid ("restrictive group") and another that received > 8 ml/kg/h of fluid ("liberal group").
Patients were excluded if they were younger than 18 years; if they had severe lung disease, chronic renal insufficiency, or a physical status classification > III on the American Society of Anesthesiologists (ASA) scale; or if it was impossible to perform epidural catheter placement or thoraco-phreno-laparotomy.
All patients underwent esophagectomy carried out according to the Lewis-Tanner approach.
Data on arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the ratio PaO2/FiO2 were collected 10 min after anesthesia was induced and again 6 h after surgery. Data on the metabolic markers creatinine and lactate were collected 10 min after anesthesia induction and 6 h after surgery.
ANOVA tests were performed to determine significant differences in mean values between study groups. Independent-sample t-tests were used to test differences in mean values between the restrictive and liberal groups for each of the two sets of measurements separately (10 minutes after anesthesia induction and 6 hr after surgery). P < 0.05 was considered significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive group | Active comparator | Other: Restrictive groupPatients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells. |
| Liberal group | Active comparator | Other: Liberal groupPatients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- esophageal carcinoma
- Lewis Tanner procedure (median laparotomy and right thoracotomy)
Key exclusion criteria (6 listed)
- younger than 18 years
- severe lung disease
- chronic renal insufficiency
- a physical status classification > III on the American Society of Anesthesiologists (ASA) scale
- impossible to perform epidural catheter placement
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 |
|---|---|---|
| Restrictive groupAlso: Intraoperative restrictive fluid managementA group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery. The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells. | Other | Restrictive group |
| Liberal groupAlso: Intraoperative liberal fluid managementA group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery. The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells. | Other | Liberal group |
Primary outcome
Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)
Time frame: 10 minutes, 6 hours
At the given time point, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the PaO2/FiO2 ratio will be measured. The results of Pa02/FiO2 ratio will be compared between two groups for each time point separately.
Creatinine Values During and After Esophageal Carcinoma Surgery
Time frame: 10 minutes, 6 hours
At the given time points, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, creatinine blood levels will be measured. The results will be compared between two groups for each time point separately.
Lactate Values During and After Esophageal Carcinoma Surgery
Time frame: 10 minutes, 6 hours
At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared between two groups for each time point separately.
Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.
Time frame: 10 minutes, 6 hours
At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared inside the same group (liberal or restrictive).
2 secondary outcomes
Duration of Surgery
Time frame: End of surgery.
Total Volume of Administered Intraoperative Fluid
Time frame: End of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26088854Karaman Ilic M, Madzarac G, Kogler J, Stancic-Rokotov D, Hodoba N. Intraoperative volume restriction in esophageal cancer surgery: an exploratory randomized clinical trial. Croat Med J. 2015 Jun;56(3):290-6. doi: 10.3325/cmj.2015.56.290.
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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.
Maja Karaman Ilić, MD PhD principal investigator
Clinical Hospital Centre Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrictive group and Liberal group in people with Esophageal Neoplasm, run by Klinički Bolnički Centar Zagreb 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 2 inclusion and 6 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 26 May 2014. 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?
Yes. Results are posted in the registry (first posted 26 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio) (time frame: 10 minutes, 6 hours). The study lists 4 primary outcomes in all. 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 NCT02033213, which also lists 1 linked publication.
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 26 May 2014.