Postoperative CarePhase 3GRICS IINCT01946269
Goal-Directed Therapy in Cancer Surgery
A Phase 3 study testing Goal-directed Resuscitation Therapy (GDT) and Standard protocol in people with Postoperative Care, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether a goal-directed resuscitation therapy within the first 8 hours after major abdominal cancer surgery reduces postoperative complications compared to a standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Care
- What is being tested?
- Goal-directed Resuscitation Therapy (GDT) and Standard protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2013to May 2014
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to ICU in immediate postoperatory of major abdominal surgery for cancer treatment
- Age over 18 years-old
Who cannot join
- Weight under 55 kilograms or over 140 kilograms;
- Contra-indication for invasive hemodynamic monitoring;
- Expected ICU permanence less than 24 hours;
- Active bleeding
- Vasoplegic shock with noradrenaline dose higher than 1mcg/kg/min
- Enrolled in other study
- Refuse to consent
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Intensive Care Unit of the Cancer Institute of Sao Paulo State
São Paulo, São Paulo, 01246000
Aline Müller, MD, 55-11-974130225, dra.alinemuller@gmail.com
Aline Müller, MD
About this study
Official title: Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study
The purpose of this study is to determine whether a goal-directed resuscitation therapy within the first 8 hours after major abdominal cancer surgery reduces postoperative complications compared to a standard therapy.
- Conditions
- Postoperative Care
- Being tested
- Goal-directed Resuscitation Therapy (GDT), Standard protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed Resuscitation Therapy (GDT)Other
- A target value of a cardiac index (CI) greater than 2.5 L/min/m2 and a mean arterial pressure of 70 mmHg will be sought.
- The first step will be fluid resuscitation with 200ml aliquots of Lactated Ringer's solution plus human albumin 20% 50 mL whenever the CI is lower than 2.5 L/min/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period or CI increases less than 10%.
- When the CI is lower than or equal to 2.5L/min/m2 despite of fluid challenge, dobutamine will be initiated with increasing doses up to 20mcg/kg/min.
- The final step will be red blood transfusion to reach a hematocrit higher than 28%.
- If necessary, norepinephrine infusion will be used to maintain a mean arterial pressure above 70 mmHg.
Standard protocolOther
The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Active comparator | Not described Receives: Other: Standard protocol |
| Goal-directed therapy (GDT) protocol | Active comparator | Not described Receives: Other: Goal-directed Resuscitation Therapy (GDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of death or major postoperative complications
Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.
Measured: 30 days after randomization
Secondary outcomes (9)
Duration of ICU stay and hospital stay
To compare the number of days of ICU stay and hospital stay between groups.
Measured: 30 days after randomization
Tissue hypoperfusion markers
To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.
Measured: 7 days after randomization
Daily SOFA score
Daily sequential organ failure assessment score within the first 7 days after randomization
Measured: 7 days after randomization
Cardiovascular complications
To compare the incidence of cardiovascular complications between groups. Cardiovascular complications will be defined as myocardial ischemia, acute decompensated heart failure, mesenteric ischemia, pulmonary thromboembolism and peripheral vascular ischemia.
Measured: 30 days after randomization
Respiratory complications
Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria
Measured: 30 days after randomization
Severe Renal complication
Severe renal complication will be defined as renal failure according to Acute Kidney Injury Network (AKIN) stage 3.
Measured: 30 days after randomization
Neurological complications
To compare the incidence of stroke between groups within 30 days after randomization.
Measured: 30 days after randomization
Severe infectious complications
To compare the incidence, between groups, of infectious complications defined as a new septic shock.
Measured: 30 days after randomization
Surgical complications
To compare the incidence between groups of surgical complication. Surgical complication will be defined as reoperation due to any reason, hospital readmission or death
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative CareStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ludhmila Abrahão Hajjar, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946269
- Sponsor's protocol ID
- GRICS-02
- Acronym
- GRICS II
- Status last verified
- Sep 2013
- First submitted
- 16 Sep 2013
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gerent ARM, Almeida JP, Fominskiy E, Landoni G, de Oliveira GQ, Rizk SI, Fukushima JT, Simoes CM, Ribeiro U Jr, Park CL, Nakamura RE, Franco RA, Candido PI, Tavares CR, Camara L, Dos Santos Rocha Ferreira G, de Almeida EPM, Filho RK, Galas FRBG, Hajjar LA. Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis. Crit Care. 2018 May 23;22(1):133. doi: 10.1186/s13054-018-2055-4.
PubMed 29792232
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study
- ClinicalTrials.gov ID
- NCT01946269
- Acronym / sponsor ID
- GRICS II / GRICS-02
- Conditions
- Postoperative Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 19 Sep 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.
The purpose of this study is to determine whether a goal-directed resuscitation therapy within the first 8 hours after major abdominal cancer surgery reduces postoperative complications compared to a standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | Active comparator | Other: Standard protocol |
| Goal-directed therapy (GDT) protocol | Active comparator | Other: Goal-directed Resuscitation Therapy (GDT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted to ICU in immediate postoperatory of major abdominal surgery for cancer treatment
- Age over 18 years-old
Key exclusion criteria (7 listed)
- Weight under 55 kilograms or over 140 kilograms;
- Contra-indication for invasive hemodynamic monitoring;
- Expected ICU permanence less than 24 hours;
- Active bleeding
- Vasoplegic shock with noradrenaline dose higher than 1mcg/kg/min
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 |
|---|---|---|
| Goal-directed Resuscitation Therapy (GDT)* A target value of a cardiac index (CI) greater than 2.5 L/min/m2 and a mean arterial pressure of 70 mmHg will be sought. * The first step will be fluid resuscitation with 200ml aliquots of Lactated Ringer's solution plus human albumin 20% 50 mL whenever the CI is lower than 2.5 L/min/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period or CI increases less than 10%. * When the CI is lower than or equal to 2.5L/min/m2 despite of fluid challenge, dobutamine will be initiated with increasing doses up to 20mcg/kg/min. * The final step will be red blood transfusion to reach a hematocrit higher than 28%. * If necessary, norepinephrine infusion will be used to maintain a mean arterial pressure above 70 mmHg. | Other | Goal-directed therapy (GDT) protocol |
| Standard protocolThe control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring. | Other | Standard group |
Primary outcome
Composite endpoint of death or major postoperative complications
Time frame: 30 days after randomization
Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.
9 secondary outcomes
Duration of ICU stay and hospital stay
Time frame: 30 days after randomization
Tissue hypoperfusion markers
Time frame: 7 days after randomization
Daily SOFA score
Time frame: 7 days after randomization
Cardiovascular complications
Time frame: 30 days after randomization
Respiratory complications
Time frame: 30 days after randomization
Severe Renal complication
Time frame: 30 days after randomization
Neurological complications
Time frame: 30 days after randomization
Severe infectious complications
Time frame: 30 days after randomization
Surgical complications
Time frame: 30 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
- Derived from this study: PubMed 29792232Gerent ARM, Almeida JP, Fominskiy E, Landoni G, de Oliveira GQ, Rizk SI, Fukushima JT, Simoes CM, Ribeiro U Jr, Park CL, Nakamura RE, Franco RA, Candido PI, Tavares CR, Camara L, Dos Santos Rocha Ferreira G, de Almeida EPM, Filho RK, Galas FRBG, Hajjar LA. Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis. Crit Care. 2018 May 23;22(1):133. doi: 10.1186/s13054-018-2055-4.
Related trials for Postoperative Care
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
Not yet recruitingPhase 4
Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
Heart Failure, Cardiac Surgery
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Goal-directed Resuscitation Therapy (GDT) and Standard protocol in people with Postoperative Care, run by University of Sao Paulo at 1 site in Brazil.
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 7 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 19 Sep 2013. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Aline Müller, MD (55-11-974130225, dra.alinemuller@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of death or major postoperative complications (time frame: 30 days after randomization). 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 NCT01946269, 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 19 Sep 2013.