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Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Cytoreductive Surgery

NCT03519165CompletedNAINTERVENTIONAL

Summary

This is a single center prospective randomized controlled study comparing the postoperative outcome after cytoreductive surgery in ovarian cancer patient after using restrictive or individualized goal-directed fluid replacement strategy (GDT). Aim of this study will be to test the hypothesis that intra-operative SVV-guided fluid optimization during ovarian cancer cytoreductive surgery: 1. reduces the postoperative length of hospital stay, 2. cost-effective, 3. GDT will be more beneficial in cases of PDS compared to IDS or cytoreductive procedures of shorter duration. 4. GDT improves intraoperative tissue perfusion/ oxygenation and improves immediate postoperative morbidity. Intra-operatively fluid of choice in both groups will be lactate-free crystalloid at 1.0 ml/kg/h for maintenance and gelofusine for fluid bolus of 3ml/kg over 5 minutes. In group C intraoperative fluid therapy will include maintenance fluid and replacement of the surgical loss. Aim will be to maintain MAP \> 65 mmHg, CVP 8-12 cm H2O and urine output \> 0.5 ml/kg/h. In group G intraoperative fluid therapy will be targeted to SVV \<13%, SVI \> 35ml/m2/ beat, SVRI more than equal to 1900 dynes-sec/cm-5/m2 in addition to clinical parameters like MAP, CVP and urine output. Primary outcome will be length of hospital stay (LOS). Secondary outcomes will be cost of surgical treatment episode (admission till fit to discharge), postoperative morbidity survey (POMS) and 30 day morbidity and mortality.

Key Facts

Lead Sponsor

Tata Medical Center

Enrollment

145

Start Date

2016-06-01

Completion Date

2019-06-01

Study Type

INTERVENTIONAL

Official Title

Restrictive or Individualized Goal-Directed Fluid Replacement Strategy in Ovarian Cancer Cytoreductive Surgery- A Prospective Randomized Controlled Trial

Interventions

EV1000(FloTrac System 4.0)

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

* Cytoreductive surgery for ovarian cancer-

  * PDS: primary (chemo-naïve patients including completion staging/ primary debulking and secondary cytoreduction)
  * IDS: interval debulking surgery (after chemotherapy)
* American Society of Anesthesiology (ASA-PS) score of 1 - 3
* Age more than 18 years and less than 65 years
* Surgery of duration more than 240 minutes
* Presumed blood loss more than 500 ml
* Elective surgery

Exclusion Criteria:

* Patient refusal
* Inability to give consent
* Laparoscopic surgery, Emergency surgery, patients undergoing HIPEC
* Age younger than 18 years \& more than 65 yrs, BMI \> 40
* Patients with LVEF \< 30%, Arrhythmia, Acute MI (within 30 days)
* COPD with FEV1 \< 50%
* Coagulopathy (platelet \<50000/μL, aPTT \> x2 control, INR \>1.5)
* Significant liver dysfunction (liver enzymes \>x3 times normal)
* Significant renal dysfunction (creatinine \>x2 times normal)
* Psychiatric disorders
* Sepsis or SIRS
* Hypersensitivity to Gelofusine

Outcome Measures

Primary Outcomes

Postoperative length of Stay (LOS) in hospital in days

From day of surgery to the day of fit to discharge

Time frame: through study completion, an average of 2 years

Secondary Outcomes

Cost of treatment

cost of treatment includes direct medical cost and out of pocket expenditure

Time frame: through study completion, an average of 2 years

Post operative morbidity survey (POMS survey)

The postoperative morbidity survey (POMS) is a nine-domain (Pulmonary, infection, renal, GIT, CVS, Neurological, haematological, wound and pain) system that prospectively identifies short-term morbidity after surgery. For each of the nine domains morbidity is recorded on the presence or absence of preset criteria.(PubMed ID: 10439777)

Time frame: on 1,3,5 and 7th postoperative day and through study completion, an average of 2 years

30 day morbidity and mortality

No. of patients in each group with grade 3 to 5 postoperative complications (Clavien-Dindo Classification) and description of complication

Time frame: through study completion, an average of 2 years

Locations

Tata Medical Centre, Kolkata, India