NCT01946269

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 19, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

September 16, 2013

Last Update Submit

September 18, 2013

Conditions

Postoperative Care

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days after randomization

Secondary Outcomes (9)

  • Duration of ICU stay and hospital stay

    30 days after randomization

  • Tissue hypoperfusion markers

    7 days after randomization

  • Daily SOFA score

    7 days after randomization

  • Cardiovascular complications

    30 days after randomization

  • Respiratory complications

    30 days after randomization

  • +4 more secondary outcomes

Study Arms (2)

Standard group

ACTIVE COMPARATOR
Other: Standard protocol

Goal-directed therapy (GDT) protocol

ACTIVE COMPARATOR
Other: Goal-directed Resuscitation Therapy (GDT)

Interventions

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.

Goal-directed therapy (GDT) protocol
Standard protocolOTHER

The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.

Standard group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to ICU in immediate postoperatory of major abdominal surgery for cancer treatment
  • Age over 18 years-old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit of the Cancer Institute of Sao Paulo State

São Paulo, São Paulo, 01246000, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29792232DERIVED

MeSH Terms

Interventions

AIEOP acute lymphoblastic leukemia protocol

Central Study Contacts

Aline Müller, MD

CONTACT

55-11-974130225dra.alinemuller@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 16, 2013

First Posted

September 19, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

September 19, 2013

Record last verified: 2013-09

Locations

BR(1)