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A clinical study to see the effects of two different methods of fluid administration (Fluid volumeestimated by anaesthetist compared with volume estimated by a machine) during Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy

ABSTRACT: Intervention1: Stroke volume variation (SVV) (using Flotrac) guided fluid therapy: The CI will be maintained at values greater than or equal to 2.5 l/min/m2 , stroke volume variation 12%, Stroke Volume Index (SVI) 35ml/m2/ beat, Systemic Vascular Resistance Index (SVRI) more than equal to 1900 dynes-sec/cm-5/m2 . Basal infusion of crystalloids will be at 4 ml/kg/h. If CI 2.5 l/min/m2, SVI 35 ml/m2 and SVV 12% crystalloid challenge and colloid bolus will be given. In the case of CI 2.5 l/min/m2 and SVI 35 ml/m2 with SVV 12% an infusion with dobutamine will be initiated alongwith colloid bolus. Control Intervention1: Fluid therapy guided by clinical parameters like mean arterial pressure (MAP), central venous pressure (CVP) and urine output: to maintain end organ perfusion, general fluid management with IV infusion of crystalloid (lactate free) will be done aiming at a Mean arterial pressure (MAP) of 65 mm Hg, urinary output of at least 0.5 (CRS phase), 2 (HIPEC phase), and 1 (post HIPEC phase) ml/ kg/ hr, respectively and CVP of 8-12 mm hg. Basal infusion of crystalloid will be at 4 ml/kg/hour, with bolus of crystalloid, colloid and use of noradrenaline depending on MAP, Urine output and CVP. Primary outcome(s): Serum Lactate levelsTimepoint: At baseline, then at one hour interval during Cytoreductive phase, half hourly interval during HIPEC phase and every 6 hourly interval post operatively for 24 hours. Study Design: Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded

DISEASE(S): Malignant Neoplasm Of Rectum,Malignant Neoplasm Of Small Intestine,Malignant Neoplasm Of Stomach,Malignant Neoplasm Of Pancreas,Malignant Neoplasm Of Ovary,Malignant Neoplasm Of Colon

PROVIDER: 2597788 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Cerebral ischemia/reperfusion injury (CI/RI), including neurological behavior deficits, cerebral infarction, blood-brain barrier (BBB) dysfunction, and neuroinflammation, et al. is a severe challenge in treatment of ischemic stroke. Traditional Chinese medicine (TCM) with the characteristics of multi-components and multi-functions for multiple targets/pathways has been historically used in the treatment of stroke and post stroke recovery in China. QiShenYiQi (QSYQ), a representative component-based Chinese medicine, is capable of reducing organ injury caused by ischemia/reperfusion via multiple mechanisms. Recently, we have previously reported that the positive action of QSYQ against the acute phase of CI/RI is partly via modulation of neuroinflammatory response. However, the effects and underlying mechanisms of QSYQ on subacute phase of CI/RI remain unknown, which are aimed to investigate in present study. The pharmacological action of QSYQ treatment on brain damage was estimated in the experimental stroke rats underwent 90 min ischemia and 8 days reperfusion by assessing the neurological and locomotor deficits, cerebral infarction, brain edema, and BBB integrity. Furthermore, we used TMT-based quantitative proteomics technology to identify significantly differentially expressed proteins following QSYQ treatment, which could give important clues for revealing the possible mechanism underlying the positive role of QSYQ in CI/RI. Besides, immunohistochemistry, western blot analysis, RT-qPCR, and rat ELISA kits were executed to further verify the accuracy of proteomics analysis results. As a consequence, we found that treatment with QSYQ (600mg/kg) for 7 days obviously improved neurological and behavioral impairment, attenuated infarct volume and brain edema, and alleviated BBB breakdown in stroke rats. Bioinformatics analysis suggested that differentially expressed protein galectin-3 mediated inflammatory response was closely related to the beneficial effect of QSYQ. Results of immunohistochemistry, western blot analysis and RT-qPCR showed that the model rats treated with QSYQ (600mg/kg) markedly downregulated the mRNA and protein expression level of galectin-3 in brain tissues compared to the untreated stroke rats. In addition, the decrease of mRNA level in brain tissues and contents in serum of TNF-α and IL-6 following QSYQ treatment were also observed. These interesting finding manifested that the effective action of QSYQ against subacute phase of CI/RI was partly via regulating galectin-3 mediated inflammatory reaction.

Dataset Information

A clinical study to see the effects of two different methods of fluid administration (Fluid volumeestimated by anaesthetist compared with volume estimated by a machine) during Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy

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