Abdominal TumorNCT02977429
Evaluation of Pcv-aCO2 in the Fluid Treatment of Abdominal Tumor Patients After Surgery
A study testing standardized fluid therapy and conventional fluid therapy in people with Abdominal Tumor and Abdominal Infection, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This research will confirm that Pcv-aCO2 is suitable for the guidance of early fluid therapy and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal tumor surgery, and is expected to be a new monitoring index to improve the therapeutic effect of these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Tumor, Abdominal Infection
- What is being tested?
- standardized fluid therapy and conventional fluid therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Sep 2018
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acute physiology and chronic health score system II (APACHE II) score ≥10；
- Hemodynamic abnormalities post-operation (a. systolic blood pressure<90mmHg, or descent by basic blood pressure for more than 40mmHg. b. pulse pressure <20mmHg, c. urine volume <0.5ml/Kg/hr, d. heart rate >100 / min, e.Central Venous Pressure(CVP) <5mmHg, f. blood lactic acid >2.7mmol/L, meet any one above).
- Age ≥ 18 years, which is expected to stay in ICU for 5 days or longer;
- Patients themselves or their authorized clients agree to participate in clinical trials and signed informed consent.
Who cannot join
- age <18 years;
- without improvement in respiratory system disease or chronic obstructive pulmonary disease with Forced expiratory volume in one second (FEV1) <50%;
- lobectomy and pneumonectomy;
- death within 24 after treatment;
- patients with severe organ dysfunction;
- pregnant or lactating women;
- the patients did not sign informed consent;
- any factors that may be expected to increase the risk of patients or other factors that may interfere with the results of clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Wanhua Wang, director, 23340123 ext. 1021, Wanhua_Wang1962@outlook.com
About this study
Official title: Clinical Study of Central Venous-to-Arterial Carbon Dioxide Difference(Pcv-aCO2) in the Evaluation of Fluid Therapy for Postoperative Patients With Abdominal Cancer
This research will confirm that Pcv-aCO2 is suitable for the guidance of early fluid therapy and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal tumor surgery, and is expected to be a new monitoring index to improve the therapeutic effect of these patients.
Read the detailed description
- Confirmed that Pcv-aCO2 is suitable for the guidance of early fluid therapy and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal tumor surgery, and is expected to be a new monitoring index to improve the therapeutic efficacy of this kind of patients.
- Pcv-aCO2 effectively reflected the improvement of tissue and organ microcirculation disorder through the individual goal target treatment to guide the fluid resuscitation in the hemodynamic instability patients.
- Research of the correlation between Pcv-aCO2 and the organ function in patients with abnormal hemodynamics after operation.
- Conditions
- Abdominal Tumor, Abdominal Infection
- Being tested
- standardized fluid therapy, conventional fluid therapy
- Keywords
- Tumor, Abdominal infection, Hemodynamics, Pcv-aCO2, Early Goal-directed Therapy (EGDT)
- Medical subject headings
- Abdominal Neoplasms, Intraabdominal Infections, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized fluid therapyOther
Also called Therapeutic effect of fluid resuscitation
The patients with ScvO2 <70% will receive the standardized fluid therapy for 6 hours.
conventional fluid therapyOther
The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.
| Study group | Role | What they receive |
|---|---|---|
| standard group | Active comparator | The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.than collect the data of ScvO2 and Pcv-aCO2:
ScvO2≥70%，and furthermore, Pcv-aCO2 is divided into "≤6mmHg" and ">6mmHg" Receives: Other: conventional fluid therapy |
| control group | Sham comparator | The patients with ScvO2 <70% will receive the standardized fluid therapy for 6 hours.than collect the data of ScvO2 and Pcv-aCO2:
ScvO2<70%，and furthermore, Pcv-aCO2 is divided into "≤6mmHg" and ">6mmHg" Receives: Other: standardized fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Pcv-aCO2
The change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
Measured: fluid resuscitation for 6 hours, 12 hours and 24 hours
Secondary outcomes (3)
The treatment success rate in different groups
Collect the index of treatment success rate(%) of patients in different groups.
Measured: Twenty-eighth days after admission
The 28 day mortality in different groups
Collect the index of 28 day mortality(%) of patients in different groups.
Measured: Twenty-eighth days after admission
The hospitalization course in different groups
Collect the index of hospitalization course(days) of patients in different groups.
Measured: Twenty-eighth days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal TumorStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanhua Wang, director, Study director, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977429
- Sponsor's protocol ID
- bc2016032
- Status last verified
- Oct 2016
- First submitted
- 9 Oct 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Futier E, Robin E, Jabaudon M, Guerin R, Petit A, Bazin JE, Constantin JM, Vallet B. Central venous O(2) saturation and venous-to-arterial CO(2) difference as complementary tools for goal-directed therapy during high-risk surgery. Crit Care. 2010;14(5):R193. doi: 10.1186/cc9310. Epub 2010 Oct 29.
PubMed 21034476Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
PubMed 20179283Pope JV, Jones AE, Gaieski DF, Arnold RC, Trzeciak S, Shapiro NI; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of central venous oxygen saturation (ScvO(2)) as a predictor of mortality in patients with sepsis. Ann Emerg Med. 2010 Jan;55(1):40-46.e1. doi: 10.1016/j.annemergmed.2009.08.014. Epub 2009 Oct 25.
PubMed 19854541Harilall Y, Adam JK, Biccard BM, Reddi A. Correlation between cerebral tissue and central venous oxygen saturation during off-pump coronary bypass graft surgery. Perfusion. 2011 Mar;26(2):83-90. doi: 10.1177/0267659110387846. Epub 2010 Nov 15.
PubMed 21078769
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Central Venous-to-Arterial Carbon Dioxide Difference(Pcv-aCO2) in the Evaluation of Fluid Therapy for Postoperative Patients With Abdominal Cancer
- ClinicalTrials.gov ID
- NCT02977429
- Acronym / sponsor ID
- bc2016032
- Conditions
- Abdominal Tumor, Abdominal Infection
- Keywords
- Tumor, Abdominal infection, Hemodynamics, Pcv-aCO2, Early Goal-directed Therapy (EGDT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 30 Nov 2016 (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.
This research will confirm that Pcv-aCO2 is suitable for the guidance of early fluid therapy and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal tumor surgery, and is expected to be a new monitoring index to improve the therapeutic effect of these patients.
Detailed description
- Confirmed that Pcv-aCO2 is suitable for the guidance of early fluid therapy and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal tumor surgery, and is expected to be a new monitoring index to improve the therapeutic efficacy of this kind of patients.
- Pcv-aCO2 effectively reflected the improvement of tissue and organ microcirculation disorder through the individual goal target treatment to guide the fluid resuscitation in the hemodynamic instability patients.
- Research of the correlation between Pcv-aCO2 and the organ function in patients with abnormal hemodynamics after operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard group | Active comparator | Other: conventional fluid therapyThe patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.than collect the data of ScvO2 and Pcv-aCO2: ScvO2≥70%，and furthermore, Pcv-aCO2 is divided into "≤6mmHg" and ">6mmHg" |
| control group | Sham comparator | Other: standardized fluid therapyThe patients with ScvO2 <70% will receive the standardized fluid therapy for 6 hours.than collect the data of ScvO2 and Pcv-aCO2: ScvO2<70%，and furthermore, Pcv-aCO2 is divided into "≤6mmHg" and ">6mmHg" |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute physiology and chronic health score system II (APACHE II) score ≥10；
- Hemodynamic abnormalities post-operation (a. systolic blood pressure<90mmHg, or descent by basic blood pressure for more than 40mmHg. b. pulse pressure <20mmHg, c. urine volume <0.5ml/Kg/hr, d. heart rate >100 / min, e.Central Venous Pressure(CVP) <5mmHg, f. blood lactic acid >2.7mmol/L, meet any one above).
- Age ≥ 18 years, which is expected to stay in ICU for 5 days or longer;
- Patients themselves or their authorized clients agree to participate in clinical trials and signed informed consent.
Key exclusion criteria (8 listed)
- age <18 years;
- without improvement in respiratory system disease or chronic obstructive pulmonary disease with Forced expiratory volume in one second (FEV1) <50%;
- lobectomy and pneumonectomy;
- death within 24 after treatment;
- patients with severe organ dysfunction;
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 |
|---|---|---|
| standardized fluid therapyAlso: Therapeutic effect of fluid resuscitationThe patients with ScvO2 <70% will receive the standardized fluid therapy for 6 hours. | Other | control group |
| conventional fluid therapyThe patients with ScvO2 ≥ 70% will receive the conventional fluid therapy. | Other | standard group |
Primary outcome
The change of Pcv-aCO2
Time frame: fluid resuscitation for 6 hours, 12 hours and 24 hours
The change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
3 secondary outcomes
The treatment success rate in different groups
Time frame: Twenty-eighth days after admission
The 28 day mortality in different groups
Time frame: Twenty-eighth days after admission
The hospitalization course in different groups
Time frame: Twenty-eighth days after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Background: PubMed 21034476Futier E, Robin E, Jabaudon M, Guerin R, Petit A, Bazin JE, Constantin JM, Vallet B. Central venous O(2) saturation and venous-to-arterial CO(2) difference as complementary tools for goal-directed therapy during high-risk surgery. Crit Care. 2010;14(5):R193. doi: 10.1186/cc9310. Epub 2010 Oct 29.
- Background: PubMed 20179283Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
- Background: PubMed 19854541Pope JV, Jones AE, Gaieski DF, Arnold RC, Trzeciak S, Shapiro NI; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of central venous oxygen saturation (ScvO(2)) as a predictor of mortality in patients with sepsis. Ann Emerg Med. 2010 Jan;55(1):40-46.e1. doi: 10.1016/j.annemergmed.2009.08.014. Epub 2009 Oct 25.
- Background: PubMed 21078769Harilall Y, Adam JK, Biccard BM, Reddi A. Correlation between cerebral tissue and central venous oxygen saturation during off-pump coronary bypass graft surgery. Perfusion. 2011 Mar;26(2):83-90. doi: 10.1177/0267659110387846. Epub 2010 Nov 15.
- Individual participant dataSharing planned: Yes
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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.
Wanhua Wang, director study director
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized fluid therapy and conventional fluid therapy in people with Abdominal Tumor and Abdominal Infection, run by Tianjin Medical University Cancer Institute and 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 4 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: status not confirmed, as of the sponsor's last update on 30 Nov 2016. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Yang, physician (022-23340123 ext. 1021, yyicu3021@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Pcv-aCO2 (time frame: fluid resuscitation for 6 hours, 12 hours and 24 hours). 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 NCT02977429, which also lists 4 linked publications.
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 30 Nov 2016.