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. 2019 Dec 12;2019(12):CD012767. doi: 10.1002/14651858.CD012767.pub2

Phan 2014.

Methods Study type: parallel RCT
Location: Australia ‐ St Vincent’s Hospital campus, St Vincent’s Public Hospital, and St Vincent’s Private Hospital, Fitzroy, Victoria
Number of centres: 3
Duration of study: June 2012 to December 2013
Follow‐up: 30 days
Protocol: ACTRN12612000717853
Participants Inclusion criteria

  1. Undergoing major colorectal surgery

  2. Suitable for enhanced recovery after surgery care pathway

  3. ASA I to III


Exclusion criteria

  1. ASA IV

  2. Pregnancy

  3. Inability to give informed consent

  4. Emergency surgery

  5. Significant renal dysfunction (estimated glomerular filtration rate < 50 mL/min)

  6. Hepatic dysfunction

  7. Severe heart failure (New York Heart Association classification 3 or 4)

  8. Age < 18 years

  9. Oesophageal pathology (such as varices), which is a relative contraindication to an oesophageal probe


Total number of participants: 100 randomized (50 in RFT and 50 in GDFT); 100 analysed (50 in RFT and 50 in GDFT)
Characteristics

  1. Age, mean (SD): RFT: 65 (19.9); GDFT: 63.1 (23.8)

  2. Female, n (%): RFT: 19 (38); GDFT: 20 (40)

  3. Type of surgery: abdominal ‐ major colorectal surgery (either laparoscopic or open)

  4. Stratification: randomization stratified to either stoma or non‐stomal pathway to ensure equal numbers in each group

  5. Type of anaesthesia: mixed ‐ all participants had a general anaesthetic technique. Epidural analgesia was utilized for planned open surgery if there were no contraindications. Transversus abdominal plane blocks were also utilized when appropriate

  6. ASA I, n (%): RFT: NR; GDFT: NR

  7. ASA II, n (%): RFT: NR; GDFT: NR

  8. ASA III, n (%): RFT: NR; GDFT: NR


Comorbidities, n (%)

  1. Ischaemic heart disease: RFT: 3 (6); GDFT: 2 (4)

  2. Congestive heart failure: RFT: 1 (2); GDFT: 2 (4)

  3. Atrial fibrillation: RFT: 0 (0); GDFT: 5 (10)

  4. Renal impairment (Cr > 130 μmol/L): RFT: 0 (0); GDFT: 1 (2)

  5. Chronic obstructive airways disease or asthma: RFT: 10 (20); GDFT: 7 (14)

  6. Cerebrovascular accident: RFT: 0 (0); GDFT: 1 (2)

  7. Inflammatory bowel disease: RFT: 8 (16); GDFT: 14 (28)

  8. Diabetes mellitus: RFT: 5 (10); GDFT: 7 (14)

  9. Smokers: RFT: 9 (18); GDFT: 4 (8)


Intraoperative fluids (mL)

  1. Total volume of fluids ‐ median (IQR): RFT: 1500 (1200 to 2000); GDFT: 2190 (1350 to 2560)

  2. Total volume of crystalloids ‐ median (IQR): RFT: 1400 (1000 to 1900); GDFT: 1500 (1000 to 2000)

  3. Total volume of colloids ‐ median (IQR): RFT: 0 (0 to 300); GDFT: 500 (250 to 750)


Preoperative fluid deficit: absent ‐ Nutricia PreOp* 2 × 200 mL carbohydrate drinks were given to participants the day before surgery and 2 hours before surgery
Interventions Treatment groups

  1. RFT ‐ study "restrictive" group ‐ Nutricia PreOp* 2 × 200 mL carbohydrate drink (the day before surgery and 2 hours before surgery). Basal 5 mL/kg/h Hartmann’s solution. Boluses only to replace blood loss or hypotension not responsive to vasopressor

  2. GDFT ‐ study "Doppler‐guided" group ‐ a similar protocol as in "restrictive" group, except during the time of the intraoperative intervention, an ODM was utilized to facilitate targeting colloid boluses to fluid responsiveness as indicated by a change in stroke volume index (SVI) > 10% and a corrected flow time interval < 350 milliseconds. Anaesthetists were asked to adhere to the SV optimization algorithm, which stipulates administration of a 250‐mL bolus of a colloid, although the colloid type was determined at the discretion of the anaesthetist. Colloid boluses were starch colloids (4% hydroxyethyl starch, Voluven®, or Volulyte® (Fresenius Kabi Pty Ltd, Bad Homburg vor der Höhe, Hesse, Germany) 180/0.3), 4% Gelofusine® (B Braun, Melsungen, Germany), or 4% human serum albumin


Concomitant treatment in both groups
Postoperative fluids for both groups followed an identical regimen: a maintenance rate of 0.5 mL/kg/h Hartmann’s solution (minimum 40 mL/h) for the first 24 hours, with additional boluses allowed for hypotension or urine output < 30 mL/h for 4 hours
Outcomes Primary outcomes

  1. Length of stay


Secondary outcomes

  1. Number of participants suffering any complication

  2. Number of participants suffering from major complications (Clavien‐Dindo grade 3 or higher)

  3. Intravenous fluid volumes administered to participants

  4. Change in participants’ haemodynamic parameters
Notes Funding: supported by St Vincent’s Hospital Research Endowment Fund 2012, AUD $20,000
Conflict of interest: NR
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization with sealed opaque envelopes was done through a computer‐generated randomization sequence and occurred on the day of surgery just before the anaesthetic was administered
Allocation concealment (selection bias) Low risk Randomization with sealed opaque envelopes was done through a computer‐generated randomization sequence and occurred on the day of surgery just before the anaesthetic was administered
Blinding of participants and personnel (performance bias) 
 Primary outcome ‐ Major complications Low risk Outcome unlikely to be influenced by lack of blinding (objective outcome). The anaesthetist was not blinded. However, the participant, the surgical team, and data collectors were blinded. Anasthesiologist had a protocol of fluid management
Blinding of participants and personnel (performance bias) 
 Primary outcome ‐ All‐cause mortality Low risk Outcome unlikely to be influenced by lack of blinding (objective outcome). The anaesthetist was not blinded. However, the participant, the surgical team, and data collectors were blinded. Anasthesiologist had a protocol of fluid management
Blinding of participants and personnel (performance bias) 
 Secondary outcome ‐ Length of hospital stay Low risk The anaesthetist was not blinded. However, the participant, the surgical team, and data collectors were blinded. Anasthesiologist had a protocol of fluid management
Blinding of participants and personnel (performance bias) 
 Secondary outcome ‐ Surgery‐related complications Low risk The anaesthetist was not blinded. However, the participant, the surgical team, and data collectors were blinded. Anasthesiologist had a protocol of fluid management
Blinding of participants and personnel (performance bias) 
 Secondary outcome ‐ Non‐surgery‐related complications Low risk The anaesthetist was not blinded. However, the participant, the surgical team, and data collectors were blinded. Anasthesiologist had a protocol of fluid management
Blinding of participants and personnel (performance bias) 
 Secondary outcome ‐ Renal failure Low risk The anaesthetist was not blinded. However, the participant, the surgical team, and data collectors were blinded. Anasthesiologist had a protocol of fluid management
Blinding of outcome assessment (detection bias) 
 Primary outcome ‐ Major complications Low risk Outcome unlikely to be influenced by lack of blinding (objective outcome). All postoperative data were collected by a research nurse or a research registrar who was blinded to the allocation
Blinding of outcome assessment (detection bias) 
 Primary outcome ‐ All‐cause mortality Low risk Outcome unlikely to be influenced by lack of blinding (objective outcome). All postoperative data were collected by a research nurse or a research registrar who was blinded to the allocation
Blinding of outcome assessment (detection bias) 
 Secondary outcome ‐ Length of hospital stay Low risk All postoperative data were collected by a research nurse or a research registrar who was blinded to the allocation
Blinding of outcome assessment (detection bias) 
 Secondary outcome ‐ Surgery‐related complications Low risk All postoperative data were collected by a research nurse or a research registrar who was blinded to the allocation
Blinding of outcome assessment (detection bias) 
 Secondary outcome ‐ Non‐surgery‐related complications Low risk All postoperative data were collected by a research nurse or a research registrar who was blinded to the allocation
Blinding of outcome assessment (detection bias) 
 Secondary outcome ‐ Renal failure Low risk All postoperative data were collected by a research nurse or a research registrar who was blinded to the allocation
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Intention‐to‐treat analysis; no loss to follow‐up (LTFU)
Selective reporting (reporting bias) Low risk All outcome data provided as described in protocol
Other bias Low risk None identified